Genetic Testing in Guiding Treatment for Patients with Brain Metastases

Status: Active

Description

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

Eligibility Criteria

Inclusion Criteria

  • PRE-REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)
  • Tissue available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy).
  • REGISTRATION ELIGIBILITY CRITERIA (ALL PATIENTS)
  • Participants must have histologically confirmed metastatic disease to the brain from any solid tumor. Note: this includes patients that have controlled extracranial disease with progressive intracranial metastasis, as well as patients that have progressive intracranial and extracranial disease.
  • New or progressive brain metastases are defined as any one of the following: * Untreated measurable lesions in patients who have received surgery and/or stereotactic radiosurgery (SRS) to one or more other lesions. * Residual or progressive lesions after surgery if asymptomatic. * Patients who have had prior whole-brain radiotherapy (WBRT) and/or SRS and then whose lesions have progressed by BM-RANO criteria or there are new lesions, are eligible. Lesions treated with SRS may be eligible if there is unequivocal evidence of progression. * Patients who have not previously been treated with cranial radiation (e.g. WBRT or SRS) are eligible, but such patients must be asymptomatic or neurologically stable from their CNS metastases.
  • Measurable CNS disease (> 10 mm).
  • Ability to obtain magnetic resonance imaging (MRI)s.
  • No surgery within 2 weeks prior to or after registration.
  • No chemotherapy within 14 days prior to registration. * For melanoma, patients must have progressed after prior immune checkpoint blockade or for BRAF positive melanoma, BRAF/MEK inhibitors. * For lung cancer, EGFR mutant patients must have failed EGFR therapies * For HER2-positive breast cancer patients, patients must have received at least one prior HER-2 directed therapy in the metastatic setting. * For triple negative breast cancer (TNBC), patients must have received at least one chemotherapy in the metastatic setting. * For estrogen receptor (ER)/progesterone receptor (PR)+ breast cancer, patients must have received at least one endocrine therapy in the metastatic setting. * Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4 pathway alteration on a biopsy at the point of progression post-ribociclib or palbociclib.
  • Tissue available for sequencing (any brain metastasis tissue and extracranial site from any prior resection or biopsy that was resected as part of clinical care). If the patient does not have any evidence of extracranial disease, brain metastasis tissue is sufficient for eligibility.
  • Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site.
  • Not pregnant and not nursing, because this study involves investigational agents whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 14 days prior to registration is required.
  • No known leptomeningeal involvement.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Adequate organ function.
  • Absolute neutrophil count (ANC) >= 1,500/mm^3.
  • Platelet count >= 100,000/mm^3.
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) except in patients with Gilbert’s disease.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN).
  • Creatinine =< 1.5 mg/dL OR calculated (Calc.) creatinine clearance > 45 mL/min.
  • No uncontrolled medical comorbidities per investigator discretion.
  • Concurrent radiation to symptomatic non-target sites within neural axis is allowed (provided there is at least one untreated target lesion).
  • Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration.
  • No concurrent administration of anticancer therapies (except for endocrine therapy or continuation of hormonal therapy or trastuzumab in breast cancer patients). No chemotherapy, targeted therapy or immunotherapy within 14 days prior to entering the study.
  • Chronic concomitant treatment with strong inhibitors of CYP3A4 is not allowed on this study. Patients on strong CYP3A4 inhibitors must discontinue the drug 14 days prior to registration on the study.
  • Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.
  • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR GDC-0084 ARM
  • Urine protein to creatinine (UPC) ratio < 1 or urine protein =< 1.
  • Recent acute myocardial infarction in the last 6 months or current angina pectoris are excluded. Patients with symptomatic bradycardia should have an electrocardiogram at baseline. If QT interval > 470 msec, the patient is excluded.
  • Patients with uncontrolled type I or II diabetes mellitus should be excluded. Uncontrolled diabetes is defined as glycosylated hemoglobin (HbA1c) > 9% in addition to fasting glucose > 140 mg/dL on at least 2 occasions within 14 days prior to registration.
  • ADDITIONAL REGISTRATION ELIGIBILITY CRITERIA FOR ENTRECTINIB ARM
  • Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.

Locations & Contacts

Alaska

Anchorage
Alaska Breast Care and Surgery LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Oncology and Hematology LLC
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Alaska Women's Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Associates in Radiation Medicine
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Oncology Centre
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Anchorage Radiation Therapy Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Katmai Oncology Group
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org
Providence Alaska Medical Center
Status: Active
Contact: Site Public Contact
Phone: 907-212-6871
Email: AKPAMC.OncologyResearchSupport@providence.org

Arkansas

Ft. Smith
Mercy Hospital Fort Smith
Status: Active
Contact: Site Public Contact
Phone: 800-378-9373
Hot Springs
CHI Saint Vincent Cancer Center Hot Springs
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

California

Burbank
Providence Saint Joseph Medical Center / Disney Family Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 818-847-4793
Email: Najee.Boucher@providence.org
Dublin
Epic Care-Dublin
Status: Active
Contact: Site Public Contact
Phone: 925-875-1677
Emeryville
Bay Area Breast Surgeons Inc
Status: Active
Contact: Site Public Contact
Phone: 510-835-9900
Epic Care Partners in Cancer Care
Status: Active
Contact: Site Public Contact
Phone: 510-629-6682
La Jolla
UC San Diego Moores Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 858-822-5354
Email: cancercto@ucsd.edu
Martinez
Contra Costa Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 925-957-5400
Oakland
Alta Bates Summit Medical Center - Summit Campus
Status: Active
Contact: Site Public Contact
Phone: 510-204-1414
Bay Area Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 510-465-2242
Email: lradke@bati.org
Orange
UC Irvine Health / Chao Family Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-827-8839
Email: ucstudy@uci.edu
Walnut Creek
Epic Care Cyberknife Center
Status: Active
Contact: Site Public Contact
Phone: 510-465-8016
Email: somega@bati.org

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Penrose
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Denver
Porter Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Durango
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Southwest Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lakewood
Saint Anthony Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Littleton
Littleton Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Longmont
Longmont United Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Rocky Mountain Cancer Centers-Longmont
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Parker
Parker Adventist Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Pueblo
Saint Mary Corwin Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 404-778-1868

Idaho

Boise
Saint Alphonsus Cancer Care Center-Boise
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute
Status: Active
Contact: Site Public Contact
Phone: 208-381-2774
Email: eslinget@slhs.org
Caldwell
Saint Alphonsus Cancer Care Center-Caldwell
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Coeur D'Alene
Kootenai Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Emmett
Walter Knox Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Meridian
Idaho Urologic Institute-Meridian
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Meridian
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Nampa
Saint Alphonsus Medical Center-Nampa
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Luke's Mountain States Tumor Institute - Nampa
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org
Post Falls
Kootenai Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Sandpoint
Kootenai Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: Active
Contact: Site Public Contact
Phone: 208-381-8059
Email: hallsc@slhs.org

Illinois

Aurora
Rush - Copley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com
Chicago
Northwestern University
Status: Active
Contact: Site Public Contact
Phone: 312-695-1301
Email: cancer@northwestern.edu
Rush University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 312-942-5498
Email: clinical_trials@rush.edu
University of Illinois
Status: Active
Contact: Site Public Contact
Phone: 312-355-3046
Danville
Carle on Vermilion
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Effingham
Carle Physician Group-Effingham
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Lake Forest
Northwestern Medicine Lake Forest Hospital
Status: Active
Contact: Site Public Contact
Email: cancertrials@northwestern.edu
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Mount Vernon
Good Samaritan Regional Health Center
Status: Active
Contact: Site Public Contact
Phone: 618-242-4600
Urbana
Carle Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
The Carle Foundation Hospital
Status: Active
Contact: Site Public Contact
Phone: 800-446-5532
Email: Research@carle.com
Yorkville
Rush-Copley Healthcare Center
Status: Active
Contact: Site Public Contact
Phone: 630-978-6212
Email: Cancer.Research@rushcopley.com

Iowa

Ames
Mary Greeley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
McFarland Clinic PC - Ames
Status: Active
Contact: Site Public Contact
Phone: 515-239-4734
Email: ksoder@mcfarlandclinic.com
Boone
McFarland Clinic PC-Boone
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Clive
Medical Oncology and Hematology Associates-West Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Cancer Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Council Bluffs
Alegent Health Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Creston
Greater Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Des Moines
Broadlawns Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: Active
Contact: Site Public Contact
Phone: 515-282-2921
Medical Oncology and Hematology Associates-Laurel
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Mercy Medical Center - Des Moines
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Fort Dodge
McFarland Clinic PC-Trinity Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Trinity Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 515-574-8302
Jefferson
McFarland Clinic PC-Jefferson
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
Marshalltown
McFarland Clinic PC-Marshalltown
Status: Active
Contact: Site Public Contact
Phone: 515-956-4132
West Des Moines
Mercy Medical Center-West Lakes
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Methodist West Hospital
Status: Active
Contact: Site Public Contact
Phone: 515-343-1000

Kentucky

Bardstown
Flaget Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Corbin
Commonwealth Cancer Center-Corbin
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lexington
Saint Joseph Hospital East
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Saint Joseph Radiation Oncology Resource Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
University of Kentucky / Markey Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 859-257-3379
London
Saint Joseph London
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Louisville
Jewish Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Jewish Hospital Medical Center Northeast
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Saints Mary and Elizabeth Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Shepherdsville
Jewish Hospital Medical Center South
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Louisiana

New Orleans
Louisiana State University Health Science Center
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu
University Medical Center New Orleans
Status: Active
Contact: Site Public Contact
Phone: 504-210-3539
Email: emede1@lsuhsc.edu

Massachusetts

Boston
Alliance for Clinical Trials in Oncology
Status: Active
Contact: Priscilla Kaliopi Brastianos
Phone: 617-643-1938
Email: pbrastianos@partners.org
Dana-Farber Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 877-442-3324
Massachusetts General Hospital Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-726-5130
Springfield
Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 413-748-9234

Michigan

Adrian
Hickman Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 517-265-0116
Ann Arbor
Saint Joseph Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Brighton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Canton
IHA Hematology Oncology Consultants-Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Canton
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Caro
Caro Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Chelsea
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Clarkston
Hematology Oncology Consultants-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Newland Medical Associates-Clarkston
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Detroit
Ascension Saint John Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
East China
Great Lakes Cancer Management Specialists-Doctors Park
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesee Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Genesys Hurley Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Hurley Medical Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Grosse Pointe Woods
Academic Hematology Oncology Specialists
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Grosse Pointe Woods
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Lansing
Sparrow Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Livonia
Hope Cancer Clinic
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Mary Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Township
Great Lakes Cancer Management Specialists-Macomb Medical Campus
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Macomb Township
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Marlette
Saint Mary's Oncology / Hematology Associates of Marlette
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Monroe
Toledo Clinic Cancer Centers-Monroe
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561
Novi
Ascension Providence Hospitals - Novi
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Pontiac
21st Century Oncology-Pontiac
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Hope Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Newland Medical Associates-Pontiac
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint Joseph Mercy Oakland
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Rochester Hills
Great Lakes Cancer Management Specialists-Rochester Hills
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saginaw
Ascension Saint Mary's Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Oncology Hematology Associates of Saginaw Valley PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Southfield
Ascension Providence Hospitals - Southfield
Status: Active
Contact: Site Public Contact
Phone: 248-849-5332
Email: karen.fife@ascension.org
Sterling Heights
Bhadresh Nayak MD PC-Sterling Heights
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Tawas City
Ascension Saint Joseph Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Warren
Advanced Breast Care Center PLLC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Great Lakes Cancer Management Specialists-Macomb Professional Building
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Macomb Hematology Oncology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Michigan Breast Specialists-Warren
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Saint John Macomb-Oakland Hospital
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Ypsilanti
Huron Gastroenterology PC
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
IHA Hematology Oncology Consultants-Ann Arbor
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org

Minnesota

Burnsville
Fairview Ridges Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Cambridge
Cambridge Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Coon Rapids
Mercy Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Edina
Fairview-Southdale Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Fridley
Unity Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maple Grove
Fairview Maple Grove Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint John's Hospital - Healtheast
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Minneapolis
Abbott-Northwestern Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Health Partners Inc
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Hennepin County Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Monticello
Monticello Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
New Ulm
New Ulm Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Princeton
Fairview Northland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Robbinsdale
North Memorial Medical Health Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Rochester
Mayo Clinic
Status: Active
Contact: Site Public Contact
Phone: 855-776-0015
Saint Cloud
Coborn Cancer Center at Saint Cloud Hospital
Status: Active
Contact: Site Public Contact
Phone: 877-229-4907
Email: coborncancercenter@centracare.com
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Saint Paul
Regions Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
United Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Shakopee
Saint Francis Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Stillwater
Lakeview Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Waconia
Ridgeview Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Willmar
Rice Memorial Hospital
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com
Wyoming
Fairview Lakes Medical Center
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Mississippi

Jackson
University of Mississippi Medical Center
Status: Active
Contact: Site Public Contact
Phone: 601-815-6700

Missouri

Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
Status: Active
Contact: Site Public Contact
Phone: 314-251-7058
Branson
Cox Cancer Center Branson
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Columbia
University of Missouri - Ellis Fischel
Status: Active
Contact: Site Public Contact
Phone: 573-882-7440
Joplin
Freeman Health System
Status: Active
Contact: Site Public Contact
Phone: 417-347-4030
Email: LJCrockett@freemanhealth.com
Mercy Hospital Joplin
Status: Active
Contact: Site Public Contact
Phone: 417-556-3074
Email: esmeralda.carrillo@mercy.net
Rolla
Delbert Day Cancer Institute at PCRMC
Status: Active
Contact: Site Public Contact
Phone: 573-458-8776
Email: kaysmith@phelpshealth.org
Mercy Clinic-Rolla-Cancer and Hematology
Status: Active
Contact: Site Public Contact
Phone: 573-458-8776
Email: kaysmith@phelpshealth.org
Saint Joseph
Heartland Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 816-271-7937
Email: linda.schumacher@mymlc.com
Saint Louis
Mercy Hospital Saint Louis
Status: Active
Contact: Site Public Contact
Phone: 314-251-7066
Mercy Hospital South
Status: Active
Contact: Site Public Contact
Email: janet.lesko@mercy.net
Saint Louis Cancer and Breast Institute-South City
Status: Active
Contact: Site Public Contact
Phone: 314-353-1870
Springfield
CoxHealth South Hospital
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Mercy Hospital Springfield
Status: Active
Contact: Site Public Contact
Phone: 417-269-4520
Washington
Mercy Hospital Washington
Status: Active
Contact: Site Public Contact
Phone: 636-390-1600

Montana

Anaconda
Community Hospital of Anaconda
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Billings
Billings Clinic Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Bozeman
Bozeman Deaconess Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls
Benefis Healthcare- Sletten Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Great Falls Clinic
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Kalispell
Kalispell Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Missoula
Community Medical Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org
Saint Patrick Hospital - Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 406-327-3118
Email: amy.hanneman@providence.org

Nebraska

Grand Island
CHI Health Saint Francis
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Kearney
CHI Health Good Samaritan
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Lincoln
Saint Elizabeth Regional Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Omaha
Alegent Health Bergan Mercy Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Alegent Health Immanuel Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Alegent Health Lakeside Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Creighton University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Papillion
Midlands Community Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

New York

Elmira
Arnot Ogden Medical Center / Falck Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 607-271-7000
Glens Falls
Glens Falls Hospital
Status: Active
Contact: Site Public Contact
Phone: 518-926-6700

North Carolina

Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 877-668-0683
Email: cancerclinicaltrials@med.unc.edu
Charlotte
Atrium Health Pineville / LCI-Pineville
Status: Active
Contact: Site Public Contact
Phone: 980-442-2000
Carolinas Medical Center / Levine Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Concord
Atrium Health Cabarrus / LCI-Concord
Status: Active
Contact: Site Public Contact
Phone: 800-804-9376
Durham
Duke University Medical Center
Status: Active
Contact: Site Public Contact
Phone: 888-275-3853

Ohio

Cincinnati
Bethesda North Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Good Samaritan Hospital - Cincinnati
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Anderson
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
TriHealth Cancer Institute-Westside
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Perrysburg
Mercy Health Perrysburg Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 419-479-5605
Email: pshoup@toledoclinic.com
Toledo
Mercy Saint Anne Hospital
Status: Active
Contact: Site Public Contact
Phone: 419-407-1160
Toledo Clinic Cancer Centers-Toledo
Status: Active
Contact: Site Public Contact
Phone: 800-444-3561

Oklahoma

Oklahoma City
Mercy Hospital Oklahoma City
Status: Active
Contact: Site Public Contact
Phone: 405-752-3402
University of Oklahoma Health Sciences Center
Status: Active
Contact: Site Public Contact
Phone: 405-271-8777
Email: ou-clinical-trials@ouhsc.edu

Oregon

Baker City
Saint Alphonsus Medical Center-Baker City
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bend
Saint Charles Health System
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909
Email: nosall@stcharleshealthcare.org
Clackamas
Clackamas Radiation Oncology Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Oncology and Hematology Care Southeast
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Coos Bay
Bay Area Hospital
Status: Active
Contact: Site Public Contact
Phone: 541-269-8392
Email: cherie.cox@bayareahospital.org
Newberg
Providence Newberg Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Ontario
Saint Alphonsus Medical Center-Ontario
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Portland
Providence Portland Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Providence Saint Vincent Medical Center
Status: Active
Contact: Site Public Contact
Phone: 503-215-2614
Email: CanRsrchStudies@providence.org
Redmond
Saint Charles Health System-Redmond
Status: Active
Contact: Site Public Contact
Phone: 541-706-2909

Pennsylvania

Allentown
Lehigh Valley Hospital-Cedar Crest
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
Bethlehem
Lehigh Valley Hospital - Muhlenberg
Status: Active
Contact: Site Public Contact
Phone: 734-712-3671
Email: stephanie.couch@stjoeshealth.org
East Stroudsburg
Pocono Medical Center
Status: Active
Contact: Site Public Contact
Phone: 570-422-1700
Email: ann.foster@lvhn.org
Hazleton
Lehigh Valley Hospital-Hazleton
Status: Active
Contact: Site Public Contact
Phone: 570-501-1242
Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Contact: Site Public Contact
Phone: 412-647-8073
UPMC-Magee Womens Hospital
Status: Active
Contact: Site Public Contact
Phone: 412-647-2811

Texas

Bryan
Saint Joseph Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: Active
Contact: Site Public Contact
Phone: 888-424-2100
Email: cancerinfo@hci.utah.edu

Vermont

Berlin
Central Vermont Medical Center / National Life Cancer Treatment
Status: Active
Contact: Site Public Contact
Phone: 802-225-5400
Burlington
University of Vermont and State Agricultural College
Status: Active
Contact: Site Public Contact
Phone: 802-656-8990
Email: rpo@uvm.edu
University of Vermont Medical Center
Status: Active
Contact: Site Public Contact
Phone: 802-656-4101
Email: rpo@uvm.edu

Virginia

Fairfax
Inova Fair Oaks Hospital
Status: Active
Contact: Site Public Contact
Phone: 703-720-5210
Email: Stephanie.VanBebber@inova.org
Inova Schar Cancer Institute
Status: Active
Contact: Site Public Contact
Phone: 703-720-5210
Email: Stephanie.VanBebber@inova.org

Washington

Aberdeen
Providence Regional Cancer System-Aberdeen
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Bellingham
PeaceHealth Saint Joseph Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-715-4133
Email: mjohnson9@peacehealth.org
Bremerton
Harrison HealthPartners Hematology and Oncology-Bremerton
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Harrison Medical Center
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Burien
Highline Medical Center-Main Campus
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Centralia
Providence Regional Cancer System-Centralia
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Edmonds
Swedish Cancer Institute-Edmonds
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Enumclaw
Saint Elizabeth Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Everett
Providence Regional Cancer Partnership
Status: Active
Contact: Site Public Contact
Phone: 425-261-3529
Email: marilyn.birchman@providence.org
Federal Way
Saint Francis Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Issaquah
Swedish Cancer Institute-Issaquah
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Kennewick
Kadlec Clinic Hematology and Oncology
Status: Active
Contact: Site Public Contact
Phone: 509-783-4637
Email: research@kadlecmed.org
Lacey
Providence Regional Cancer System-Lacey
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Lakewood
Saint Clare Hospital
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Longview
PeaceHealth Saint John Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-2016
Email: kmakin-bond@peacehealth.org
Poulsbo
Harrison HealthPartners Hematology and Oncology-Poulsbo
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Seattle
Pacific Gynecology Specialists
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Ballard Campus
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-Cherry Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Swedish Medical Center-First Hill
Status: Active
Contact: Site Public Contact
Phone: 206-215-3086
Email: PCRC-NCORP@Swedish.org
Sedro-Woolley
PeaceHealth United General Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-788-8240
Shelton
Providence Regional Cancer System-Shelton
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org
Tacoma
Franciscan Research Center-Northwest Medical Plaza
Status: Active
Contact: Site Public Contact
Phone: 308-398-6518
Email: clinicaltrials@sfmc-gi.org
Vancouver
PeaceHealth Southwest Medical Center
Status: Active
Contact: Site Public Contact
Phone: 360-514-3940
Email: kmakin-bond@peacehealth.org
Walla Walla
Providence Saint Mary Regional Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 509-897-5993
Email: Cheryl.Dodd@providence.org
Yelm
Providence Regional Cancer System-Yelm
Status: Active
Contact: Site Public Contact
Phone: 360-412-8958
Email: deidre.dillon@providence.org

Wisconsin

Milwaukee
Medical College of Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 414-805-3666
New Richmond
Cancer Center of Western Wisconsin
Status: Active
Contact: Site Public Contact
Phone: 952-993-1517
Email: mmcorc@healthpartners.com

Wyoming

Cody
Billings Clinic-Cody
Status: Active
Contact: Site Public Contact
Phone: 800-996-2663
Email: research@billingsclinic.org
Sheridan
Welch Cancer Center
Status: Active
Contact: Site Public Contact
Phone: 406-969-6060
Email: mccinfo@mtcancer.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the activity of a CDK inhibitor in patients with progressive brain metastases derived from lung cancer, breast cancer, and other cancers harboring actionable genetic alterations associated with sensitivity to CDK inhibitors as measured by response rate (Response Assessment in Neuro-Oncology [RANO] criteria).

II. To determine the activity of a PI3K inhibitor in patients with progressive brain metastases derived from lung cancer, breast cancer, and other cancers harboring actionable genetic alterations in the PI3K pathway as measured by response rate (RANO criteria).

III: To determine the activity of an NTRK/ROS1 inhibitor in patients with progressive brain metastases derived from lung cancer harboring actionable NTRK/ROS1 gene fusions as measured by response rate (RANO criteria).

SECONDARY OBJECTIVES:

I. To evaluate the systemic response by Response Evaluation Criteria in Solid Tumors (RECIST) criteria in each of the cohorts determined by treatment and primary cancer type.

II. To evaluate the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD]) by Brain Metastases (BM)-RANO for central nervous system (CNS) in each of the cohorts determined by treatment and primary cancer type.

III. To evaluate the clinical benefit rate (CR + PR + SD) by RECIST for extracranial disease in each of the cohorts determined by treatment and primary cancer type.

IV. To evaluate the duration of response by BM-RANO in each of the cohorts determined by treatment and primary cancer type.

V. To evaluate the duration of response by RECIST in each of the cohorts determined by treatment and primary cancer type.

VI. To evaluate the progression-free survival for intracranial disease in each of the cohorts determined by treatment and primary cancer type.

VII. To evaluate the progression-free survival for extracranial disease in each of the cohorts determined by treatment and primary cancer type.

VIII. To evaluate the site of first progression (CNS versus [vs] non-CNS) in each of the cohorts determined by treatment and primary cancer type.

IX. To evaluate the overall survival in each of the cohorts determined by treatment and primary cancer type.

X. To evaluate the toxicity profile of agents in patients with brain metastases in each of the cohorts determined by treatment and primary cancer type.

OTHER OBJECTIVES:

I. Results of the primary analysis will be examined for consistency, while taking into account the stratification factors.

CORRELATIVE SCIENCE OBJECTIVES:

I. To evaluate imaging markers of response in brain metastases.

OUTLINE: Patients are assigned to 1 of 3 arms.

ARM I (CDK GENE MUTATION): Patients receive abemaciclib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II (PI3K GENE MUTATION): Patients receive PI3K inhibitor GDC-0084 PO once daily (QD) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM III (NTRK/ROS1 GENE MUTATION): Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 8 weeks for 2 years, then every 3 months for years 3-4, and then every 6 months thereafter for up to 5 years after registration.

Trial Phase & Type

Trial Phase

Phase II

Trial Type

Treatment

Lead Organization

Lead Organization
Alliance for Clinical Trials in Oncology

Principal Investigator
Priscilla Kaliopi Brastianos

Trial IDs

Primary ID A071701
Secondary IDs NCI-2019-00744
Clinicaltrials.gov ID NCT03994796