Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas

THE STUDY

About this study

This phase II trial studies how well vismodegib, focal adhesion kinase (FAK) inhibitor GSK2256098, and capivasertib work in treating patients with meningioma that is growing, spreading, or getting worse (progressive). Vismodegib, FAK inhibitor GSK2256098, capivasertib, and abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Full official title

Phase II Trial of SMO/ AKT/ NF2/CDK Inhibitors in Progressive Meningiomas With SMO/ AKT/ NF2/CDK Pathway Mutations

Detailed description

PRIMARY OBJECTIVES:

I. To determine the activity of a SMO inhibitor in patients with meningiomas harboring SMO and PTCH1 mutations as measured by 6-month progression free survival (PFS) and response rate.

II. To determine the activity of a FAK inhibitor in patients with meningiomas harboring NF2 mutations as measured by 6-month PFS and response rate.

III. To determine the activity of an AKT inhibitor in patients with meningiomas harboring AKT1/PIK3CA/PTEN mutations as measured by 6-month PFS and response rate.

IV. To determine the activity of a CDK inhibitor in patients with meningiomas harboring alterations in the CDK pathway or NF2 alterations as measured by 6-month PFS and response rate.

SECONDARY OBJECTIVES:

I. To determine overall survival and progression-free survival of SMO, FAK, AKT and CDK inhibitors in patients with meningioma.

II. To determine adverse event rates of SMO, FAK, AKT and CDK inhibitors in patients with meningioma.

III. To determine the activity of SMO, FAK, AKT and CDK inhibitors as measured by response rate by central radiology review.

OUTLINE: Patients are assigned to 1 of 4 treatment arms based on their mutation status.

ARM A (SMO/PTCH1 mutation): Patients receive vismodegib orally (PO) once daily (QD). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)

ARM B (NF2 mutation): Patients receive FAK inhibitor GSK2256098 PO twice daily (BID). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)

ARM C (AKT1, PIK3CA, or PTEN mutation): Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.

ARM D (CDK4, CDK6, CDKN2A, CCND1, CCND2, CCND3, CCNE1 alterations): Patients receive abemaciclib PO every 12 hours (Q12H). Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6 months for a maximum of 5 years from registration.

PARTICIPATION

Who may participate

Minimum age: 18 Years
Maximum age: Not reported
Sex eligibility: All sexes
Healthy volunteers: Not accepted

Only the study team can confirm eligibility. The registry criteria below are not a medical recommendation.

Full inclusion and exclusion criteria

* Documentation of disease:

* Histologic documentation: histologically proven intracranial meningioma as documented by central pathology review
* Molecular documentation: Presence of SMO, PTCH1, NF2, CDKN2A, AKT1, PIK3CA, PTEN mutations, CDKN2A copy number loss, CDK4, CDK6, CCND1, CCND2, CCND3, or CCNE1 copy number gain in tumor sample as documented specifically by the central laboratory, regardless of whether prior genotype testing outside of the central laboratory was performed
* Progressive OR residual disease, as defined by the following:

* Residual measurable disease: residual measurable disease immediately after surgery without requirement for progression; for grade I disease, progression pre-operatively needs to be documented, with an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months; for patients with SMO/PTCH1 mutations enrolling to receive vismodegib, the change can occur between scans separated by up to 25 months; residual measurable disease will be defined by bidimensionally measurable lesions with clearly defined margins by MRI scans, with a minimum diameter of 10 mm in both dimensions
* Progressive measurable disease: progression defined as an increase in size of the measurable primary lesion on imaging by 25% or more (bidirectional area); the change must occur between scans separated by no more than 25 months
* Post radiation patients: patients with measurable and progressive meningioma who have received radiation are potentially eligible, but need to show evidence of progressive disease after completion of radiation; if the progressive meningioma lesion has been radiated, at least 24 weeks must have elapsed from completion of radiation to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
* Measurable disease: measurable disease is defined by a bidimensionally measurable main lesion on MRI or computed tomography (CT) images (MRI preferred) with clearly defined margins and a minimum diameter of 10 mm in both dimensions; multifocal disease is allowed
* Prior treatment

* Prior medical therapy is allowed but not required
* No limit on number of prior therapies
* No chemotherapy, or other investigational agents within 28 days prior to registration
* No other concurrent investigational agents or other meningioma-directed therapy (chemotherapy, radiation) while on study; additionally, no cases of nitrosourea or mitomycin C within 6 weeks prior to registration
* For patients treated with external beam radiation, interstitial brachytherapy or radiosurgery, an interval \> 4 weeks must have elapsed from completion of radiation therapy to registration; if the progressive lesion is outside of the radiation field, then an interval of at least 2 weeks must have elapsed from completion of radiation to registration
* Steroid dosing stable for at least 4 days
* Recovered to Common Terminology Criteria for Adverse Events (CTCAE) grade 1 or less toxicity from other agents with exception of alopecia and fatigue
* No craniotomy 28 days prior to and after registration
* Not pregnant and not nursing:

\* A female of childbearing potential is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months)
* For patients with NF2/CDKN2A/AKT1/PIK3CA/PTEN mutation, CKDN2A copy number loss, or CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1 copy number gain: Age \>= 18 years
* For patients with SMO/PTCH1 mutation: Age \>= 30 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Patient history:

* Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for 6 months
* No metastatic meningiomas (as defined by extracranial meningiomas outside of CNS) allowed; spinal meningiomas are allowed
* No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug
* No known active hepatitis B or C
* No current Child Pugh class B or C liver disease
* No uncontrolled gastric ulcer disease (grade 3 gastric ulcer disease within 28 days of registration)
* No uncontrolled hypertension defined as blood pressure (BP) \> 140/90
* No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within 28 days prior to registration
* No major surgery within 28 days prior to registration for any patients with AKT1/PIK3CA/PTEN mutations receiving capivasertib
* For patients going on to receive capivasertib (i.e. enrolled after Update #08)

* Patients should not have any of the following cardiac criteria:

* Any clinically important abnormalities in rhythm, conduction, or morphology of resting electrocardiogram (EKG) (e.g., complete left bundle branch block, third degree heart block)
* Any factors that increase the risk of corrected QT (QTc) prolongation or risk of arrhythmic events such as heart failure, hypokalemia, potential for Torsade de Pointes, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age, or any concomitant medication known to prolong the QT interval
* Experience any of the following procedures or conditions in the preceding 6 months: coronary artery bypass graft, angioplasty, vascular stent, myocardial infarction, angina pectoris, congestive heart failure New York Heart Association (NYHA) class \>= II
* Uncontrolled hypertension (systolic blood pressure \[SBP\] \< 90 mmHg and/or diastolic blood pressure \[DBP\] \< 50 mmHg)
* Cardiac ejection fraction outside institutional range of normal or \< 50% (whichever is higher) as measured by echocardiogram (or multigated acquisition \[MUGA\] scan if an echocardiogram can't be performed or is inconclusive); left ventricular ejection fraction (LVEF) below lower limit of normal for site
* Patients should not have any of the following criteria:

* With the exception of alopecia, any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) grade 1 at the time of registration
* Hemoglobin \< 9 g/dL (\< 5.59 mmol/L); note: any blood transfusion must be \>= 14 days prior to the determination of a hemoglobin \>= 9 g/dL (\>= 5.59 mmol/L)
* Proteinuria 3+ on dipstick analysis or \> 500 mg/24 hours
* Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product or previous significant bowel resection that would preclude adequate absorption of capivasertib
* History of hypersensitivity to active or inactive excipients of capivasertib or drugs with a similar chemical structure or class to capivasertib
* Current disease or condition known to interfere with absorption, distribution, metabolism, or excretion of drugs
* Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
* Previous allogeneic bone marrow transplant
* Known immunodeficiency syndrome
* Concomitant medications (only regarding NF2/CDKN2A/CDK4/CDK6/CCND1/CCND2/CCND3/CCNE1/AKT1/PIK3CA/PTEN genetic alterations):

* Chronic concomitant treatment with strong inhibitors of cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors must discontinue the drug for 14 days prior to registration on the study for patients with NF2 mutation enrolled to GSK2256098, as well as for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib
* For NF2 patients going on to receive GSK2256098 and for patients with AKT1/PIK3CA/PTEN mutations enrolled to capivasertib: concomitant treatment with strong CYP3A4 inducers or CYP2D6 substrates is not allowed; patients must discontinue the drug 14 days prior to registration
* For NF2 patients going on to receive abemaciclib: avoid concomitant use of CYP3A inducers and strong CYP3A inhibitors; use caution with coadministered moderate or weak CYP3A inhibitors
* Diabetic status:

* For patients with NF2 or SMO/PTCH1 mutations: No uncontrolled diabetes defined as a known diabetic with HBA1C \> 7.5 OR fasting glucose \> 140 mg/dL.
* For patients with AKT1/PIK3CA/PTEN mutations:

* Glycosylated hemoglobin (HbA1C) \< 8.0% (63.9 mmol/mol)
* No type 1 diabetes mellitus
* No requirement for insulin for routine diabetic management and control
* No requirement for more than two oral hypoglycemic medications for routine diabetic management and control
* Patients with a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose \< 9.3 mmol/L (167mg/dL); fasting is defined as no caloric intake for at least 8 hours
* Patients without a pre-existing diagnosis of type 2 diabetes mellitus must have fasting glucose =\< 7.0 mmol/L (126 mg/dL); fasting is defined as no caloric intake for at least 8 hours
* Absolute neutrophil count (ANC) \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* Creatinine OR =\< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance \> 50 mL/min
* Urine protein:creatinine ratio (UPC) =\< 45 mg/mmol
* Total bilirubin =\< 1.5 x upper limit of normal (ULN); except in case of Gilbert's disease
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN
* Sodium, potassium, total calcium (corrected for serum albumin) \& phosphorus within normal limits per institutional guidelines
* QTcF \< 450 msec (QT calculated using Fridericia formula)
* Mean resting heart rate (determined from EKG) 50-100 beats per minute (BMP) (must be obtained from 12-lead EKG defined by a triplicate EKG for patients assigned to the capivasertib arm; patients assigned to all other arms will require a single EKG
* No uncontrolled medical comorbidities per investigator discretion (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, history of major surgical resection involving the stomach or small bowel, or pre-existing Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Hemoglobin \>= 8 g/dL

\* Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator; initial treatment must not begin earlier than the day after the erythrocyte transfusion
* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: Prior Treatment

* Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] grade =\< 1) from the acute effects of chemotherapy except for residual alopecia or grade 2 peripheral neuropathy prior to registration; a washout period of at least 28 days is required between last chemotherapy dose and registration (provided the patient did not receive radiotherapy)
* Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy; a washout period of at least 28 days is required between end of radiotherapy and registration
* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No active bacterial infection (requiring intravenous \[IV\] antibiotics at time of initiating study treatment), fungal infection, or detectable viral infection (such as known human immunodeficiency virus positivity or with known active hepatitis B or C \[for example, hepatitis B surface antigen positive\]); screening is not required for enrollment in the absence of symptoms
* ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ABEMACICLIB ARM: No personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest

Recruiting

Fairbanks, Alaska, 99701, United States

Site contacts (2)

Site Public ContactContactPhone: 907-458-3043Email: Veronica.Stevenson@foundationhealth.org

John M. SchallenkampPrincipal investigator

Kingman Regional Medical Center

Recruiting

Kingman, Arizona, 86401, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

Cancer Center at Saint Joseph's

Recruiting

Phoenix, Arizona, 85004, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Saint Joseph's Hospital and Medical Center

Suspended

Phoenix, Arizona, 85013, United States

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Mayo Clinic in Arizona

Withdrawn

Scottsdale, Arizona, 85259, United States

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Arizona Oncology Services Foundation

Suspended

Scottsdale, Arizona, 85260, United States

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Mercy Hospital Fort Smith

Recruiting

Fort Smith, Arkansas, 72903, United States

Site contacts (2)

Site Public ContactContactPhone: 800-378-9373

Jay W. CarlsonPrincipal investigator

CHI Saint Vincent Cancer Center Hot Springs

Suspended

Hot Springs, Arkansas, 71913, United States

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CARTI Cancer Center

Recruiting

Little Rock, Arkansas, 72205, United States

Site contacts (2)

Site Public ContactContactPhone: 501-906-4199Email: Research@CARTI.com

Jay W. CarlsonPrincipal investigator

Kaiser Permanente-Deer Valley Medical Center

Active, not recruiting

Antioch, California, 94531, United States

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Mission Hope Medical Oncology - Arroyo Grande

Recruiting

Arroyo Grande, California, 93420, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

PCR Oncology

Recruiting

Mercy San Juan Medical Center

Recruiting

Carmichael, California, 95608, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@commonspirit.org

Shahzad SiddiquePrincipal investigator

Eden Hospital Medical Center

Active, not recruiting

Castro Valley, California, 94546, United States

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Sutter Davis Hospital

Active, not recruiting

Davis, California, 95616, United States

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Mercy Cancer Center - Elk Grove

Recruiting

Elk Grove, California, 95758, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Kaiser Permanente-Fremont

Active, not recruiting

Fremont, California, 94538, United States

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Palo Alto Medical Foundation-Fremont

Active, not recruiting

Fremont, California, 94538, United States

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Kaiser Permanente-Fresno

Active, not recruiting

Fresno, California, 93720, United States

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UC San Diego Moores Cancer Center

Recruiting

La Jolla, California, 92093, United States

Site contacts (2)

Site Public ContactContactPhone: 858-822-5354Email: cancercto@ucsd.edu

David E. PiccioniPrincipal investigator

Kaiser Permanente Los Angeles Medical Center

Recruiting

Los Angeles, California, 90027, United States

Site contacts (2)

Site Public ContactContactPhone: 800-398-3996Email: clinical.trials@kp.org

Richard M. GreenPrincipal investigator

Los Angeles General Medical Center

Active, not recruiting

Los Angeles, California, 90033, United States

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USC / Norris Comprehensive Cancer Center

Active, not recruiting

Los Angeles, California, 90033, United States

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Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, 90048, United States

Site contacts (2)

Site Public ContactContactPhone: 310-423-2133Email: Cancer.trial.info@cshs.org

Jeremy D. RudnickPrincipal investigator

Mercy Cancer Center

Recruiting

Kaiser Permanente-Roseville

Active, not recruiting

Roseville, California, 95661, United States

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Sutter Cancer Centers Radiation Oncology Services-Roseville

Active, not recruiting

Roseville, California, 95661, United States

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Sutter Roseville Medical Center

Active, not recruiting

Roseville, California, 95661, United States

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Mercy Cancer Center - Sacramento

Recruiting

Recruiting

Recruiting

Santa Maria, California, 93444, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Kaiser Permanente-Santa Rosa

Active, not recruiting

Santa Rosa, California, 95403, United States

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Sutter Pacific Medical Foundation

Active, not recruiting

Santa Rosa, California, 95403, United States

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Active, not recruiting

Vallejo, California, 94589, United States

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Suspended

Denver, Colorado, 80210, United States

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CommonSpirit Cancer Center Mercy

Recruiting

Durango, Colorado, 81301, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Mercy Medical Center

Recruiting

Durango, Colorado, 81301, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Mountain Blue Cancer Care Center

Suspended

Golden, Colorado, 80401, United States

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Grand Valley Oncology

Active, not recruiting

Grand Junction, Colorado, 81505, United States

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CommonSpirit Saint Anthony Hospital Cancer Center

Recruiting

Lakewood, Colorado, 80228, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Rocky Mountain Cancer Centers-Lakewood

Suspended

Lakewood, Colorado, 80228, United States

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AdventHealth Littleton

Suspended

Littleton, Colorado, 80122, United States

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Longmont United Hospital

Recruiting

Longmont, Colorado, 80501, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Rocky Mountain Cancer Centers-Longmont

Suspended

Longmont, Colorado, 80501, United States

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AdventHealth Parker

Suspended

Parker, Colorado, 80138, United States

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Yale University

Recruiting

New Haven, Connecticut, 06520, United States

Site contacts (2)

Site Public ContactContactPhone: 203-785-5702Email: canceranswers@yale.edu

Nicholas A. BlondinPrincipal investigator

Smilow Cancer Hospital Care Center-Trumbull

Recruiting

Trumbull, Connecticut, 06611, United States

Site contacts (2)

Site Public ContactContactPhone: 203-785-5702Email: canceranswers@yale.edu

Nicholas A. BlondinPrincipal investigator

Mount Sinai Comprehensive Cancer Center at Aventura

Active, not recruiting

Aventura, Florida, 33180, United States

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Boca Raton Regional Hospital

Recruiting

Boca Raton, Florida, 33486, United States

Site contacts (2)

Site Public ContactContactPhone: 561-955-4800

Harold RichterPrincipal investigator

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Recruiting

Deerfield Beach, Florida, 33442, United States

Site contacts (2)

Site Public ContactContactPhone: 305-243-2647

Macarena I. De La FuentePrincipal investigator

Holy Cross Hospital

Recruiting

Fort Lauderdale, Florida, 33308, United States

Site contacts (2)

Site Public ContactContactEmail: eileen.georgi@holy-cross.com

Elie G. DibPrincipal investigator

UF Health Cancer Institute - Gainesville

Active, not recruiting

Gainesville, Florida, 32610, United States

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Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Recruiting

Hollywood, Florida, 33021, United States

Site contacts (2)

Site Public ContactContactPhone: 954-265-1847Email: OHR@mhs.net

Atif M. HusseinPrincipal investigator

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, 32224-9980, United States

Site contacts (2)

Site Public ContactContactPhone: 855-776-0015

Evanthia GalanisPrincipal investigator

University of Miami Miller School of Medicine-Sylvester Cancer Center

Recruiting

Miami, Florida, 33136, United States

Site contacts (2)

Site Public ContactContactPhone: 305-243-2647

Macarena I. De La FuentePrincipal investigator

Mount Sinai Medical Center

Active, not recruiting

Miami Beach, Florida, 33140, United States

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Memorial Hospital West

Recruiting

Pembroke Pines, Florida, 33028, United States

Site contacts (2)

Site Public ContactContactPhone: 954-265-4325

Atif M. HusseinPrincipal investigator

UM Sylvester Comprehensive Cancer Center at Plantation

Recruiting

Plantation, Florida, 33324, United States

Site contacts (2)

Site Public ContactContactPhone: 305-243-2647

Macarena I. De La FuentePrincipal investigator

Tampa General Hospital

Recruiting

Tampa, Florida, 33606, United States

Site contacts (2)

Site Public ContactContactPhone: 813-844-7829Email: syapchanyk@tgh.org

Sajeel A. ChowdharyPrincipal investigator

Active, not recruiting

Savannah, Georgia, 31404, United States

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Kaiser Permanente Moanalua Medical Center

Active, not recruiting

Honolulu, Hawaii, 96819, United States

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Saint Alphonsus Cancer Care Center-Boise

Suspended

Nampa, Idaho, 83687, United States

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Saint Luke's Cancer Institute - Nampa

Suspended

Nampa, Idaho, 83687, United States

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Kootenai Clinic Cancer Services - Post Falls

Recruiting

Post Falls, Idaho, 83854, United States

Site contacts (2)

Site Public ContactContactPhone: 406-969-6060Email: mccinfo@mtcancer.org

John M. SchallenkampPrincipal investigator

Kootenai Clinic Cancer Services - Sandpoint

Recruiting

Sandpoint, Idaho, 83864, United States

Site contacts (2)

Site Public ContactContactPhone: 406-969-6060Email: mccinfo@mtcancer.org

John M. SchallenkampPrincipal investigator

Saint Luke's Cancer Institute - Twin Falls

Suspended

Twin Falls, Idaho, 83301, United States

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OSF Saint Anthony's Health Center

Recruiting

Alton, Illinois, 62002, United States

Site contacts (2)

Site Public ContactContactPhone: 618-463-5623

Jay W. CarlsonPrincipal investigator

Rush-Copley Medical Center

Recruiting

Aurora, Illinois, 60504, United States

Site contacts (2)

Site Public ContactContactPhone: 630-978-6212Email: RCMC_Cancer_Research@rush.edu

Vamsi K. VasireddyPrincipal investigator

Advocate Good Shepherd Hospital

Recruiting

Barrington, Illinois, 60010, United States

Site contacts (2)

Site Public ContactContactPhone: 847-842-4847

Isaac Melguizo-GavilanesPrincipal investigator

Suspended

Centralia, Illinois, 62801, United States

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Northwestern University

Recruiting

Chicago, Illinois, 60611, United States

Site contacts (2)

Site Public ContactContactPhone: 312-695-1301Email: cancer@northwestern.edu

Priya K. BhasinPrincipal investigator

Rush MD Anderson Cancer Center

Recruiting

Chicago, Illinois, 60612, United States

Site contacts (2)

Site Public ContactContactPhone: 312-226-2371Email: Cancer_Studies@rush.edu

Joo Yeon NamPrincipal investigator

Springfield, Illinois, 62702, United States

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Southern Illinois University School of Medicine

Recruiting

Springfield, Illinois, 62702, United States

Site contacts (2)

Site Public ContactContactPhone: 217-545-7929

Bryan A. FallerPrincipal investigator

Springfield Clinic

Recruiting

Springfield, Illinois, 62702, United States

Site contacts (2)

Site Public ContactContactPhone: 800-444-7541

Bryan A. FallerPrincipal investigator

Springfield Memorial Hospital

Recruiting

Springfield, Illinois, 62781, United States

Site contacts (2)

Site Public ContactContactPhone: 217-528-7541Email: pallante.beth@mhsil.com

Bryan A. FallerPrincipal investigator

McFarland Clinic - Boone

Active, not recruiting

Boone, Iowa, 50036, United States

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Mercy Cancer Center-West Lakes

Recruiting

Clive, Iowa, 50325, United States

Site contacts (2)

Site Public ContactContactPhone: 515-241-3305

Richard L. DemingPrincipal investigator

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Recruiting

Clive, Iowa, 50325, United States

Site contacts (2)

Site Public ContactContactPhone: 515-241-3305

Seema Harichand-HerdtPrincipal investigator

Alegent Health Mercy Hospital

Suspended

Council Bluffs, Iowa, 51503, United States

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Greater Regional Medical Center

Suspended

Creston, Iowa, 50801, United States

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UI Health Care Mission Cancer and Blood - Des Moines Clinic

Recruiting

Des Moines, Iowa, 50309, United States

Site contacts (2)

Site Public ContactContactPhone: 515-241-3305

Seema Harichand-HerdtPrincipal investigator

Mercy Medical Center - Des Moines

Recruiting

Des Moines, Iowa, 50314, United States

Site contacts (2)

Site Public ContactContactPhone: 515-241-3305

Richard L. DemingPrincipal investigator

UI Health Care Mission Cancer and Blood - Laurel Clinic

Recruiting

Des Moines, Iowa, 50314, United States

Site contacts (2)

Site Public ContactContactPhone: 515-241-3305

Seema Harichand-HerdtPrincipal investigator

Mercy Hospital Pittsburg

Recruiting

Commonwealth Cancer Center-Corbin

Recruiting

Corbin, Kentucky, 40701, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Oncology Hematology Care Inc-Crestview

Suspended

Crestview Hills, Kentucky, 41017, United States

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CommonSpirit Saint Joseph Hospital - Lexington

Recruiting

Lexington, Kentucky, 40504, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Saint Joseph Radiation Oncology Resource Center

Recruiting

Lexington, Kentucky, 40504, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

CommonSpirit Saint Joseph Medical Center - East Lexington

Recruiting

Lexington, Kentucky, 40509, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

University of Kentucky/Markey Cancer Center

Active, not recruiting

Lexington, Kentucky, 40536, United States

Study team contact · shared across sites

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CommonSpirit Saint Joseph Hospital London

Recruiting

London, Kentucky, 40741, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Recruiting

Baltimore, Maryland, 21287, United States

Site contacts (2)

Site Public ContactContactPhone: 410-955-8804Email: jhcccro@jhmi.edu

Chetan BettegowdaPrincipal investigator

Tufts Medical Center

Active, not recruiting

Boston, Massachusetts, 02111, United States

Study team contact · shared across sites

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Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, 02114, United States

Site contacts (2)

Site Public ContactContactPhone: 877-726-5130

Nancy WangPrincipal investigator

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, 02215, United States

Site contacts (2)

Site Public ContactContactPhone: 877-442-3324

Ugonma N. ChukwuekePrincipal investigator

Suspended

Caro, Michigan, 48723, United States

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Chelsea Hospital

Recruiting

Chelsea, Michigan, 48118, United States

Site contacts (2)

Site Public ContactContactPhone: 734-712-7251Email: MCRCwebsitecontactform@stjoeshealth.org

Elie G. DibPrincipal investigator

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Recruiting

Chelsea, Michigan, 48118, United States

Site contacts (2)

Site Public ContactContactPhone: 734-712-7251Email: MCRCwebsitecontactform@stjoeshealth.org

Elie G. DibPrincipal investigator

Hematology Oncology Consultants-Clarkston

Recruiting

Clarkston, Michigan, 48346, United States

Site contacts (2)

Site Public ContactContactPhone: 734-712-7251Email: MCRCwebsitecontactform@stjoeshealth.org

Elie G. DibPrincipal investigator

Newland Medical Associates-Clarkston

Suspended

Clarkston, Michigan, 48346, United States

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Trinity Health IHA Medical Group - Primary Care - Clarkston

Recruiting

Clarkston, Michigan, 48346, United States

Site contacts (2)

Site Public ContactContactPhone: 248-858-6215Email: Emily.Crofts@Trinity-Health.org

Elie G. DibPrincipal investigator

Henry Ford Macomb Hospital-Clinton Township

Recruiting

Clinton Township, Michigan, 48038, United States

Site contacts (2)

Site Public ContactContactPhone: 313-916-3721Email: CTOResearch@hfhs.org

Lisa R. rogersPrincipal investigator

Kalamazoo, Michigan, 49007, United States

Site contacts (2)

Site Public ContactContactPhone: 616-391-1230Email: crcwm-regulatory@crcwm.org

Kathleen Y. ButlerPrincipal investigator

Beacon Kalamazoo Cancer Center

Suspended

Kalamazoo, Michigan, 49009, United States

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Beacon Kalamazoo

Suspended

Kalamazoo, Michigan, 49048, United States

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University of Michigan Health - Sparrow Lansing

Recruiting

Lansing, Michigan, 48912, United States

Site contacts (2)

Site Public ContactContactPhone: 517-364-3712Email: harsha.trivedi@umhsparrow.org

Elie G. DibPrincipal investigator

Hope Cancer Clinic

Suspended

Livonia, Michigan, 48154, United States

Study team contact · shared across sites

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Trinity Health Saint Mary Mercy Livonia Hospital

Recruiting

Livonia, Michigan, 48154, United States

Site contacts (2)

Site Public ContactContactPhone: 734-712-7251Email: MCRCwebsitecontactform@stjoeshealth.org

Elie G. DibPrincipal investigator

Henry Ford Saint John Hospital - Macomb Medical

Recruiting

Macomb, Michigan, 48044, United States

Site contacts (2)

Site Public ContactContactPhone: 313-343-3166Email: kforman1@hfhs.org

Elie G. DibPrincipal investigator

Henry Ford Warren Hospital - Breast Macomb

Recruiting

Macomb, Michigan, 48044, United States

Site contacts (2)

Site Public ContactContactPhone: 313-343-3166Email: kforman1@hfhs.org

Elie G. DibPrincipal investigator

Saint Mary's Oncology/Hematology Associates of Marlette

Suspended

Marlette, Michigan, 48453, United States

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MyMichigan Medical Center Midland

Recruiting

Recruiting

Pontiac, Michigan, 48341, United States

Site contacts (2)

Site Public ContactContactPhone: 734-712-7251Email: MCRCwebsitecontactform@stjoeshealth.org

Elie G. DibPrincipal investigator

Trinity Health Saint Joseph Mercy Oakland Hospital

Advanced Breast Care Center PLLC

Suspended

Warren, Michigan, 48088, United States

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Henry Ford Health Warren Hospital

Recruiting

Warren, Michigan, 48093, United States

Site contacts (2)

Site Public ContactContactPhone: 313-343-3166Email: kforman1@hfhs.org

Elie G. DibPrincipal investigator

Henry Ford Madison Heights Hospital - Breast

Recruiting

Warren, Michigan, 48093, United States

Site contacts (2)

Site Public ContactContactPhone: 313-343-3166Email: kforman1@hfhs.org

Elie G. DibPrincipal investigator

Henry Ford Warren Hospital - GLCMS

Recruiting

Warren, Michigan, 48093, United States

Site contacts (2)

Site Public ContactContactPhone: 313-343-3166Email: kforman1@hfhs.org

Elie G. DibPrincipal investigator

Macomb Hematology Oncology PC

Suspended

Warren, Michigan, 48093, United States

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Henry Ford West Bloomfield Hospital

Recruiting

West Bloomfield, Michigan, 48322, United States

Site contacts (2)

Site Public ContactContactPhone: 313-916-3721Email: CTOResearch@hfhs.org

Lisa R. rogersPrincipal investigator

Suspended

Burnsville, Minnesota, 55337, United States

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Minnesota Oncology - Burnsville

Recruiting

Burnsville, Minnesota, 55337, United States

Site contacts (2)

Site Public ContactContactPhone: 952-993-1517Email: mmcorc@healthpartners.com

Yan JiPrincipal investigator

Suspended

Fergus Falls, Minnesota, 56537, United States

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Essentia Health - Fosston

Recruiting

Fosston, Minnesota, 56542, United States

Site contacts (2)

Site Public ContactContactPhone: 218-786-3308Email: CancerTrials@EssentiaHealth.org

Bret E. FridayPrincipal investigator

Robbinsdale, Minnesota, 55422, United States

Site contacts (2)

Site Public ContactContactPhone: 952-993-1517Email: mmcorc@healthpartners.com

Yan JiPrincipal investigator

Suspended

Bolivar, Missouri, 65613, United States

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Active, not recruiting

Independence, Missouri, 64057, United States

Study team contact · shared across sites

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MU Health Care Goldschmidt Cancer Center

Suspended

Jefferson City, Missouri, 65109, United States

Study team contact · shared across sites

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Freeman Health System

Recruiting

Joplin, Missouri, 64804, United States

Site contacts (2)

Site Public ContactContactPhone: 417-347-4030Email: LJCrockett@freemanhealth.com

Jay W. CarlsonPrincipal investigator

Mercy Hospital Joplin

Recruiting

Joplin, Missouri, 64804, United States

Site contacts (2)

Site Public ContactContactPhone: 417-556-3074Email: esmeralda.carrillo@mercy.net

Jay W. CarlsonPrincipal investigator

Saint Luke's Hospital of Kansas City

Active, not recruiting

Kansas City, Missouri, 64111, United States

Study team contact · shared across sites

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Research Medical Center

Active, not recruiting

Kansas City, Missouri, 64132, United States

Study team contact · shared across sites

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Saint Luke's East - Lee's Summit

Active, not recruiting

Lee's Summit, Missouri, 64086, United States

Study team contact · shared across sites

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Recruiting

Suspended

Grand Island, Nebraska, 68803, United States

Study team contact · shared across sites

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Fred and Pamela Buffett Cancer Center - Kearney

Suspended

Kearney, Nebraska, 68845, United States

Study team contact · shared across sites

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CHI Health Good Samaritan

Recruiting

Kearney, Nebraska, 68847, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Saint Elizabeth Regional Medical Center

Suspended

Lincoln, Nebraska, 68510, United States

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Nebraska Medicine-Village Pointe

Active, not recruiting

Omaha, Nebraska, 68118, United States

Study team contact · shared across sites

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Alegent Health Immanuel Medical Center

Hope Cancer Care of Nevada

Recruiting

Las Vegas, Nevada, 89103, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

Cancer and Blood Specialists-Shadow

Suspended

Las Vegas, Nevada, 89106, United States

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Radiation Oncology Centers of Nevada Central

Recruiting

Las Vegas, Nevada, 89106, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

Urology Specialists of Nevada - Central

Recruiting

Las Vegas, Nevada, 89106, United States

Site contacts (2)

Site Public ContactContactEmail: research@sncrf.org

John A. EllertonPrincipal investigator

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Suspended

Las Vegas, Nevada, 89109, United States

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Sunrise Hospital and Medical Center

Recruiting

Las Vegas, Nevada, 89109, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Suspended

Las Vegas, Nevada, 89113, United States

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Las Vegas Prostate Cancer Center

Suspended

Las Vegas, Nevada, 89113, United States

Study team contact · shared across sites

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Las Vegas Urology - Sunset

Suspended

Las Vegas, Nevada, 89113, United States

Study team contact · shared across sites

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Urology Specialists of Nevada - Southwest

Recruiting

Las Vegas, Nevada, 89113, United States

Site contacts (2)

Site Public ContactContactEmail: research@sncrf.org

John A. EllertonPrincipal investigator

Radiation Oncology Centers of Nevada Southeast

Recruiting

Las Vegas, Nevada, 89119, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

Cancer Therapy and Integrative Medicine

Suspended

Las Vegas, Nevada, 89121, United States

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Ann M Wierman MD LTD

Suspended

Las Vegas, Nevada, 89128, United States

Study team contact · shared across sites

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Cancer and Blood Specialists-Tenaya

Suspended

Las Vegas, Nevada, 89128, United States

Study team contact · shared across sites

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Comprehensive Cancer Centers of Nevada - Northwest

Recruiting

Las Vegas, Nevada, 89128, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Suspended

Las Vegas, Nevada, 89128, United States

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Las Vegas Urology - Cathedral Rock

Suspended

Las Vegas, Nevada, 89128, United States

Study team contact · shared across sites

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Suspended

Las Vegas, Nevada, 89148-2405, United States

Study team contact · shared across sites

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Comprehensive Cancer Centers of Nevada

Recruiting

Las Vegas, Nevada, 89148, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Suspended

Las Vegas, Nevada, 89149, United States

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Comprehensive Cancer Centers of Nevada - Central Valley

Recruiting

Las Vegas, Nevada, 89169, United States

Site contacts (2)

Site Public ContactContactPhone: 702-384-0013Email: research@sncrf.org

John A. EllertonPrincipal investigator

Suspended

Reno, Nevada, 89509, United States

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Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

Recruiting

Lebanon, New Hampshire, 03756, United States

Site contacts (2)

Site Public ContactContactPhone: 800-639-6918Email: cancer.research.nurse@dartmouth.edu

Konstantin H. DragnevPrincipal investigator

Memorial Sloan Kettering Basking Ridge

Active, not recruiting

Basking Ridge, New Jersey, 07920, United States

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Active, not recruiting

New York, New York, 10029, United States

Study team contact · shared across sites

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NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

Active, not recruiting

New York, New York, 10032, United States

Study team contact · shared across sites

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Memorial Sloan Kettering Cancer Center

Active, not recruiting

New York, New York, 10065, United States

Study team contact · shared across sites

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NYP/Weill Cornell Medical Center

Recruiting

Recruiting

Essentia Health Cancer Center-South University Clinic

Recruiting

Fargo, North Dakota, 58103, United States

Site contacts (2)

Site Public ContactContactPhone: 218-786-3308Email: CancerTrials@EssentiaHealth.org

Bret E. FridayPrincipal investigator

Essentia Health - Jamestown Clinic

Recruiting

Jamestown, North Dakota, 58401, United States

Site contacts (2)

Site Public ContactContactPhone: 218-786-3308Email: CancerTrials@EssentiaHealth.org

Bret E. FridayPrincipal investigator

Indu and Raj Soin Medical Center

Active, not recruiting

Beavercreek, Ohio, 45431, United States

Study team contact · shared across sites

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Strecker Cancer Center-Belpre

Recruiting

Belpre, Ohio, 45714, United States

Site contacts (2)

Site Public ContactContactPhone: 614-488-2745Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Dayton Physicians LLC-Miami Valley South

Active, not recruiting

Centerville, Ohio, 45459, United States

Study team contact · shared across sites

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Miami Valley Hospital South

Active, not recruiting

Centerville, Ohio, 45459, United States

Study team contact · shared across sites

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Adena Regional Medical Center

Recruiting

Chillicothe, Ohio, 45601, United States

Site contacts (2)

Site Public ContactContactPhone: 877-779-7585Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Oncology Hematology Care Inc-Eden Park

Suspended

Cincinnati, Ohio, 45202, United States

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Oncology Hematology Care Inc-Mercy West

Suspended

Cincinnati, Ohio, 45211, United States

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University of Cincinnati Cancer Center-UC Medical Center

Recruiting

Cincinnati, Ohio, 45219, United States

Site contacts (2)

Site Public ContactContactPhone: 513-584-7698Email: cancer@uchealth.com

Rekha T. ChaudharyPrincipal investigator

Good Samaritan Hospital - Cincinnati

Recruiting

Cincinnati, Ohio, 45220, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Oncology Hematology Care Inc-Anderson

Suspended

Cincinnati, Ohio, 45230, United States

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Oncology Hematology Care Inc-Kenwood

Active, not recruiting

Cincinnati, Ohio, 45236, United States

Study team contact · shared across sites

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Bethesda North Hospital

Recruiting

Cincinnati, Ohio, 45242, United States

Site contacts (2)

Site Public ContactContactPhone: 720-874-1881Email: ResearchInstituteInquiries@CommonSpirit.org

Shahzad SiddiquePrincipal investigator

Active, not recruiting

Columbus, Ohio, 43210, United States

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Mount Carmel East Hospital

Recruiting

Columbus, Ohio, 43213, United States

Site contacts (2)

Site Public ContactContactPhone: 614-488-2745Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Columbus Oncology and Hematology Associates Inc

Suspended

Columbus, Ohio, 43214, United States

Study team contact · shared across sites

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Riverside Methodist Hospital

Suspended

Columbus, Ohio, 43214, United States

Study team contact · shared across sites

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Grant Medical Center

Suspended

Columbus, Ohio, 43215, United States

Study team contact · shared across sites

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The Mark H Zangmeister Center

Recruiting

Columbus, Ohio, 43219, United States

Site contacts (2)

Site Public ContactContactPhone: 614-488-2745Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Mount Carmel Health Center West

Recruiting

Recruiting

Grove City, Ohio, 43123, United States

Site contacts (2)

Site Public ContactContactPhone: 614-488-2745Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Zangmeister Center Grove City

Recruiting

Grove City, Ohio, 43123, United States

Site contacts (2)

Site Public ContactContactPhone: 614-488-2745Email: Jeffh@columbusccop.org

Aruna C. GowdaPrincipal investigator

Greater Dayton Cancer Center

Active, not recruiting

Kettering, Ohio, 45409, United States

Study team contact · shared across sites

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First Dayton Cancer Care

Active, not recruiting

Kettering, Ohio, 45420, United States

Study team contact · shared across sites

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Kettering Medical Center

Active, not recruiting

Kettering, Ohio, 45429, United States

Study team contact · shared across sites

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Fairfield Medical Center

Recruiting

Troy, Ohio, 45373, United States

Study team contact · shared across sites

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Active, not recruiting

Tulsa, Oklahoma, 74146, United States

Study team contact · shared across sites

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Saint Alphonsus Cancer Care Center-Baker City

Recruiting

Baker City, Oregon, 97814, United States

Site contacts (2)

Site Public ContactContactPhone: 406-969-6060Email: mccinfo@mtcancer.org

Elie G. DibPrincipal investigator

Saint Charles Health System

Suspended

Bend, Oregon, 97701, United States

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Clackamas Radiation Oncology Center

Recruiting

Clackamas, Oregon, 97015, United States

Site contacts (2)

Site Public ContactContactPhone: 503-215-2614Email: CanRsrchStudies@providence.org

Natasha C. EdwinPrincipal investigator

Providence Cancer Institute Clackamas Clinic

Suspended

Clackamas, Oregon, 97015, United States

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Bay Area Hospital

Suspended

Coos Bay, Oregon, 97420, United States

Study team contact · shared across sites

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Active, not recruiting

Lewistown, Pennsylvania, 17044, United States

Study team contact · shared across sites

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UPMC Cancer Center at UPMC McKeesport

Active, not recruiting

McKeesport, Pennsylvania, 15132, United States

Study team contact · shared across sites

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UPMC Hillman Cancer Center in Coraopolis

Active, not recruiting

Moon Township, Pennsylvania, 15108, United States

Study team contact · shared across sites

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University of Pennsylvania/Abramson Cancer Center

Recruiting

Philadelphia, Pennsylvania, 19104, United States

Site contacts (2)

Site Public ContactContactPhone: 215-349-8245Email: PMCancerResearch@pennmedicine.upenn.edu

Arati DesaiPrincipal investigator

UPMC-Magee Womens Hospital

Active, not recruiting

Pittsburgh, Pennsylvania, 15213, United States

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UPMC-Presbyterian Hospital

Active, not recruiting

Pittsburgh, Pennsylvania, 15213, United States

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UPMC-Saint Margaret

Active, not recruiting

Pittsburgh, Pennsylvania, 15215, United States

Study team contact · shared across sites

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UPMC Hillman Cancer Center

Recruiting

Recruiting

Boiling Springs, South Carolina, 29316, United States

Site contacts (2)

Site Public ContactContactPhone: 864-522-4317Email: Kim.Williams3@prismahealth.org

Ki Y. ChungPrincipal investigator

Medical University of South Carolina

Active, not recruiting

Charleston, South Carolina, 29425, United States

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Prisma Health Cancer Institute - Easley

Recruiting

Easley, South Carolina, 29640, United States

Site contacts (2)

Site Public ContactContactPhone: 864-522-4317Email: Kim.Williams3@prismahealth.org

Ki Y. ChungPrincipal investigator

Gibbs Cancer Center-Gaffney

Active, not recruiting

Gaffney, South Carolina, 29341, United States

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Active, not recruiting

Greer, South Carolina, 29651, United States

Study team contact · shared across sites

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Prisma Health Cancer Institute - Seneca

Recruiting

UT MD Anderson Cancer Center

Recruiting

Houston, Texas, 77030, United States

Site contacts (2)

Site Public ContactContactPhone: 866-632-6789Email: askmdanderson@mdanderson.org

Carlos Kamiya MatsuokaPrincipal investigator

Memorial Hermann Northeast Hospital

Recruiting

Humble, Texas, 77338, United States

Site contacts (2)

Site Public ContactContactPhone: 888-823-5923Email: ctsucontact@westat.com

Jay-Jiguang ZhuPrincipal investigator

University of Texas Health Science Center at San Antonio

Active, not recruiting

San Antonio, Texas, 78229, United States

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Memorial Hermann The Woodlands Hospital

Recruiting

The Woodlands, Texas, 77380, United States

Site contacts (2)

Site Public ContactContactPhone: 888-823-5923Email: ctsucontact@westat.com

Jay-Jiguang ZhuPrincipal investigator

Farmington Health Center

Active, not recruiting

Farmington, Utah, 84025, United States

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Huntsman Cancer Institute/University of Utah

Active, not recruiting

Salt Lake City, Utah, 84112, United States

Study team contact · shared across sites

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Active, not recruiting

Falls Church, Virginia, 22042, United States

Study team contact · shared across sites

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VCU Massey Comprehensive Cancer Center

Recruiting

Saint Joseph Medical Center Hematology and Oncology - Silverdale

Recruiting

Providence Regional Cancer System-Yelm

Suspended

Yelm, Washington, 98597, United States

Study team contact · shared across sites

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United Hospital Center

Active, not recruiting

Bridgeport, West Virginia, 26330, United States

Study team contact · shared across sites

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WVUH-Berkely Medical Center

Active, not recruiting

Martinsburg, West Virginia, 25401, United States

Study team contact · shared across sites

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West Virginia University Healthcare

Active, not recruiting

Morgantown, West Virginia, 26506, United States

Study team contact · shared across sites

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La Crosse, Wisconsin, 54601, United States

Study team contact · shared across sites

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Active, not recruiting

Milwaukee, Wisconsin, 53226, United States

Study team contact · shared across sites

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Aurora Sinai Medical Center

Recruiting

Milwaukee, Wisconsin, 53233, United States

Site contacts (2)

Site Public ContactContactPhone: 414-302-2304Email: ncorp@aurora.org

Isaac Melguizo-GavilanesPrincipal investigator

Marshfield Medical Center - Minocqua

Recruiting

Minocqua, Wisconsin, 54548, United States

Site contacts (2)

Site Public ContactContactPhone: 800-782-8581Email: oncology.clinical.trials@marshfieldresearch.org

Benjamin E. LawlerPrincipal investigator

ProHealth D N Greenwald Center

Suspended

Mukwonago, Wisconsin, 53149, United States

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Cancer Center of Western Wisconsin

Recruiting

New Richmond, Wisconsin, 54017, United States

Site contacts (2)

Site Public ContactContactPhone: 952-993-1517Email: mmcorc@healthpartners.com

Yan JiPrincipal investigator

Suspended

Stevens Point, Wisconsin, 54481, United States

Study team contact · shared across sites

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Marshfield Medical Center-River Region at Stevens Point

Recruiting

Stevens Point, Wisconsin, 54482, United States

Site contacts (2)

Site Public ContactContactPhone: 800-782-8581Email: oncology.clinical.trials@marshfieldresearch.org

Benjamin E. LawlerPrincipal investigator

Aurora Medical Center in Summit

Recruiting

Summit, Wisconsin, 53066, United States

Site contacts (2)

Site Public ContactContactPhone: 414-302-2304Email: ncorp@aurora.org

Isaac Melguizo-GavilanesPrincipal investigator

Vince Lombardi Cancer Clinic-Two Rivers

Recruiting

Two Rivers, Wisconsin, 54241, United States

Site contacts (2)

Site Public ContactContactPhone: 414-302-2304Email: ncorp@aurora.org

Isaac Melguizo-GavilanesPrincipal investigator

Aurora Cancer Care-Waukesha

Active, not recruiting

Waukesha, Wisconsin, 53188, United States

Study team contact · shared across sites

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ProHealth Waukesha Memorial Hospital

Suspended

Waukesha, Wisconsin, 53188, United States

Study team contact · shared across sites

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Active, not recruiting

Cody, Wyoming, 82414, United States

Study team contact · shared across sites

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Billings Clinic-Cody

Recruiting

Cody, Wyoming, 82414, United States

Site contacts (2)

Site Public ContactContactPhone: 800-996-2663Email: research@billingsclinic.org

John M. SchallenkampPrincipal investigator

Welch Cancer Center

Suspended

Sheridan, Wyoming, 82801, United States

Study team contact · shared across sites

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WHAT IS BEING STUDIED

Treatments and study groups

Interventions

VismodegibDrug

Given PO

Study groups: Arm A (vismodegib)

Other names: GDC-0449

FAK Inhibitor GSK2256098Drug

Given PO

Study groups: Arm B (FAK inhibitor GSK2256098)

CapivasertibDrug

Given PO

Study groups: Arm C (capivasertib)

Other names: AZD5363

AbemaciclibDrug

Given PO

Study groups: Arm D (abemaciclib)

Study groups

Arm A (vismodegib)Experimental

Patients receive vismodegib PO QD. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL FEBRUARY 2018)

Interventions: Drug: Vismodegib

Arm B (FAK inhibitor GSK2256098)Experimental

Patients receive FAK inhibitor GSK2256098 PO BID. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. (CLOSED TO ACCRUAL JULY 2017)

Interventions: Drug: FAK Inhibitor GSK2256098

Arm C (capivasertib)Experimental

Patients receive capivasertib PO BID on days 1-4. Treatment repeats every 7 days for up to 1 cycle (28 days) in the absence of disease progression or unacceptable toxicity.

Interventions: Drug: Capivasertib

Arm D (abemaciclib)Experimental

Patients receive abemaciclib PO Q12H. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Interventions: Drug: Abemaciclib

RESEARCH DETAILS

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non randomized
Study model: Parallel
Masking: None (open label)
Enrolment: 124 participants · Estimated

TIMELINE & MEASURES

Dates and outcomes

Study started: 28 Sep 2015 · Actual
Primary completion: 1 Jun 2028 · Estimated
Study completion: 1 Jun 2029 · Estimated
First registered: 14 Aug 2015 · Estimated
Last registry update: 19 Oct 2026 · Actual
Status last verified: Oct 2026

Primary outcomes (2)

Progression free survival (PFS)

Point estimates and 95% binomial confidence intervals will be generated for the six month PFS rate within each cohort of each treatment arm. Kaplan-Meier curves will be generated for PFS for each cohort within each treatment arm.

Time frame: At 6 months

Response rate defined as a confirmed complete response (CR) or partial response (PR)

Point estimates will be generated for response rates within each treatment arm with corresponding 95% binomial confidence intervals.

Time frame: Up to 2 years

Secondary outcomes (2)

Overall survival (OS)

OS will be summarized for each cohort within each treatment group with Kaplan-Meier curves and estimates.

Time frame: Up to 2 years

Incidence of adverse events according to National Cancer Institute CTCAE version 4.0

Adverse events (AEs) will be summarized for each treatment group. They will be summarized as the number and frequency of each event. In addition the AEs will be summarized as the number and frequency of patients who experience any AE, AEs of grade 3+, and AEs of grade 4+.

Time frame: Up to 4 weeks after completion of study treatment

STUDY TEAM

Sponsor and contacts

Lead sponsor: Alliance for Clinical Trials in Oncology
Sponsor type: Other
Collaborators: National Cancer Institute (NCI), GlaxoSmithKline, Genentech, Inc., Brain Science Foundation
Organisation study ID: A071401

Central study contacts

Priscilla Brastianos, MDContactPhone: 617-643-1939

Study officials

Priscilla Brastianos, MDStudy chair · Massachusetts General Hospital

Contacts are provided by the registry for study enquiries. Do not use these details for marketing or promotions.

Results, documents and references

No results are posted in this registry record

This does not mean the study has no findings. Results may not yet have been submitted or published here.

No study documents are listed in this record.

Publications (2)

Brastianos PK, Dooley K, Geyer S, Gerstner ER, Kaufmann TJ, Iafrate AJ, Martinez-Lage M, Milhem M, Welch MR, Kaley TJ, Drappatz J, Chan A, Kumthekar P, Matsuoka CK, Strowd RE, Cohen AL, Jaeckle K, Robell L, Magge RS, Nam JY, Blondin N, Shaikh N, Rabinowitz I, Thomas AA, Piccioni DE, Brown P, Kaluziak S, Codd E, Cahill DP, Santagata S, Barker FG 2nd, Galanis E. Abemaciclib in meningiomas with somatic NF2 or CDK pathway alterations: the phase 2 Alliance A071401 trial. Nat Med. 2026 Feb;32(2):717-724. doi: 10.1038/s41591-025-04141-4. Epub 2026 Jan 16. PubMed ↗
Brastianos PK, Twohy EL, Gerstner ER, Kaufmann TJ, Iafrate AJ, Lennerz J, Jeyapalan S, Piccioni DE, Monga V, Fadul CE, Schiff D, Taylor JW, Chowdhary SA, Bettegowda C, Ansstas G, De La Fuente M, Anderson MD, Shonka N, Damek D, Carrillo J, Kunschner-Ronan LJ, Chaudhary R, Jaeckle KA, Senecal FM, Kaley T, Morrison T, Thomas AA, Welch MR, Iwamoto F, Cachia D, Cohen AL, Vora S, Knopp M, Dunn IF, Kumthekar P, Sarkaria J, Geyer S, Carrero XW, Martinez-Lage M, Cahill DP, Brown PD, Giannini C, Santagata S, Barker FG 2nd, Galanis E. Alliance A071401: Phase II Trial of Focal Adhesion Kinase Inhibition in Meningiomas With Somatic NF2 Mutations. J Clin Oncol. 2023 Jan 20;41(3):618-628. doi: 10.1200/JCO.21.02371. Epub 2022 Oct 26. PubMed ↗