Genetic Testing in Guiding Treatment for Patients With Brain Metastases
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm
About this trial
This is an interventional treatment trial for CDK Gene 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 parenchymal 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.
- Progressive measurable lesions after radiation, surgery, or prior systemic therapy
- 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. For patients with NTRK or ROS1 mutations, entrectinib may be used for newly diagnosed brain metastases.
- 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 with contrast
- No surgery within 2 weeks prior to or after registration.
No chemotherapy within 14 days prior to registration (Note: for abemaciclib arm, a 21-day chemotherapy washout is required).
- 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 (regardless of ER/PR status), 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) and/or progesterone receptor (PR)+ HER2-negative breast cancer, patients must have received at least one endocrine therapy in the metastatic setting.
- Patients who have received prior treatment with any of the targeted treatments on this study are not eligible for that specific treatment arm(s), but could be eligible for other arms (e.g., a patient who has had prior treatment with abemaciclib would not be eligible for the abemaciclib arm, but could be eligible for another arm).
- Presence of clinically actionable alteration in NTRK, ROS1, or CDK pathway or PI3K pathway in both a brain metastasis and extracranial site per central review.
- 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 (Note: for abemaciclib arm, pregnancy test is required =< 7 days prior to registration).
- No known current diffuse leptomeningeal involvement (diffuse defined as leptomeningeal involvement throughout the CNS axis; if there is documented positive CSF cytology, patient is ineligible).
- 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. Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted.
- 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 (e.g. interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or preexisting Crohn's disease or ulcerative colitis or a preexisting chronic condition resulting in baseline Grade 2 or higher diarrhea)
- Radiation to symptomatic non-target sites within neural axis is allowed prior to registration without washout (provided there is at least one untreated target lesion for measurement on study and radiation is completed prior to registration).
- Concurrent systemic corticosteroids are allowed if stable dose of dexamethasone for 7 days prior to registration. Baseline doses and changes in steroid dosing will be captured.
- 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 (Note: For abemaciclib arm, a 21-day chemotherapy washout is required).
- 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 PAXALISIB 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 CRITERION FOR ENTRECTINIB ARM
• Concurrent use of H2 receptor antagonists, receptor antagonists, proton pump inhibitors (PPIs), and/or antacids are prohibited.
ADDITIONAL REGISTRATION ELIGIBILITY CRITERION FOR ABEMACICLIB ARM
- Hemoglobin >= 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.
- 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 21 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 14 days is required between end of radiotherapy and registration.
- Breast cancer patients who have received ribociclib or palbociclib are eligible as long as there is documentation of CDK4/6 pathway alteration on a biopsy or resection at the point of progression post-ribociclib or palbociclib.
- For females of childbearing potential: A female of childbearing potential, must have a negative serum pregnancy test within 7 days prior to registration and agree to use a highly effective contraception method during the treatment period and for 3 weeks following the last dose of abemaciclib. Contraceptive methods may include an intrauterine device [IUD] or barrier method. If condoms are used as a barrier method, a spermicidal agent should be added as a double barrier protection. Cases of pregnancy that occur during maternal exposures to abemaciclib should be reported. If a patient or spouse/partner is determined to be pregnant following abemaciclib initiation, she must discontinue treatment immediately. Data on fetal outcome and breast-feeding are to be collected for regulatory reporting and drug safety evaluation.
- Patients with 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] are excluded. Screening is not required for enrollment.
- Patients with 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, are excluded.
Sites / Locations
- Anchorage Associates in Radiation Medicine
- Anchorage Radiation Therapy Center
- Alaska Breast Care and Surgery LLC
- Alaska Oncology and Hematology LLC
- Alaska Women's Cancer Care
- Anchorage Oncology Centre
- Katmai Oncology Group
- Providence Alaska Medical Center
- Cancer Center at Saint Joseph's
- Mayo Clinic Hospital in Arizona
- Mayo Clinic in Arizona
- Mercy Hospital Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs
- Mission Hope Medical Oncology - Arroyo Grande
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Epic Care-DublinRecruiting
- Bay Area Breast Surgeons Inc
- Epic Care Partners in Cancer CareRecruiting
- UC San Diego Moores Cancer CenterRecruiting
- Cedars Sinai Medical Center
- Contra Costa Regional Medical CenterRecruiting
- Alta Bates Summit Medical Center - Summit Campus
- Bay Area Tumor Institute
- UC Irvine Health/Chao Family Comprehensive Cancer CenterRecruiting
- Sharp Memorial HospitalRecruiting
- Pacific Central Coast Health Center-San Luis Obispo
- Mission Hope Medical Oncology - Santa Maria
- Torrance Memorial Physician Network - Cancer Care
- Torrance Memorial Medical Center
- Epic Care Cyberknife CenterRecruiting
- Penrose-Saint Francis Healthcare
- Rocky Mountain Cancer Centers-Penrose
- Porter Adventist Hospital
- Mercy Medical Center
- Southwest Oncology PC
- Saint Anthony Hospital
- Littleton Adventist HospitalRecruiting
- Longmont United Hospital
- Rocky Mountain Cancer Centers-Longmont
- Parker Adventist HospitalRecruiting
- Saint Mary Corwin Medical Center
- Smilow Cancer Center/Yale-New Haven Hospital
- Yale UniversityRecruiting
- Boca Raton Regional Hospital
- UM Sylvester Comprehensive Cancer Center at Coral GablesRecruiting
- UM Sylvester Comprehensive Cancer Center at Deerfield BeachRecruiting
- Holy Cross Hospital
- Mayo Clinic in FloridaRecruiting
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Emory University Hospital Midtown
- Emory University Hospital/Winship Cancer InstituteRecruiting
- Emory Saint Joseph's Hospital
- Saint Alphonsus Cancer Care Center-BoiseRecruiting
- Saint Luke's Cancer Institute - Boise
- Saint Alphonsus Cancer Care Center-CaldwellRecruiting
- Kootenai Health - Coeur d'AleneRecruiting
- Walter Knox Memorial Hospital
- Saint Luke's Cancer Institute - Fruitland
- Idaho Urologic Institute-Meridian
- Saint Luke's Cancer Institute - Meridian
- Saint Luke's Cancer Institute - Nampa
- Saint Alphonsus Cancer Care Center-NampaRecruiting
- Kootenai Clinic Cancer Services - Post FallsRecruiting
- Kootenai Cancer ClinicRecruiting
- Saint Luke's Cancer Institute - Twin Falls
- Saint Anthony's Health
- Rush - Copley Medical Center
- Northwestern UniversityRecruiting
- Rush University Medical Center
- University of IllinoisRecruiting
- University of Chicago Comprehensive Cancer Center
- Advocate Illinois Masonic Medical CenterRecruiting
- AMG Crystal Lake - OncologyRecruiting
- Carle at The RiverfrontRecruiting
- Northwestern Medicine Cancer Center KishwaukeeRecruiting
- Carle Physician Group-EffinghamRecruiting
- Northwestern Medicine Cancer Center DelnorRecruiting
- Northwestern Medicine Lake Forest HospitalRecruiting
- Carle Physician Group-Mattoon/CharlestonRecruiting
- Good Samaritan Regional Health Center
- Advocate Lutheran General HospitalRecruiting
- Carle Cancer CenterRecruiting
- The Carle Foundation Hospital
- Northwestern Medicine Cancer Center WarrenvilleRecruiting
- Rush-Copley Healthcare Center
- Mary Greeley Medical CenterRecruiting
- McFarland Clinic - AmesRecruiting
- McFarland Clinic - BooneRecruiting
- Saint Anthony Regional HospitalRecruiting
- Medical Oncology and Hematology Associates-West Des Moines
- Mercy Cancer Center-West Lakes
- Alegent Health Mercy Hospital
- Greater Regional Medical Center
- Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates-Des MoinesRecruiting
- Broadlawns Medical CenterRecruiting
- Mercy Medical Center - Des Moines
- Mission Cancer and Blood - Laurel
- Iowa Lutheran Hospital
- McFarland Clinic - Trinity Cancer CenterRecruiting
- Trinity Regional Medical Center
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- McFarland Clinic - JeffersonRecruiting
- McFarland Clinic - MarshalltownRecruiting
- Methodist West Hospital
- Mercy Medical Center-West Lakes
- Central Care Cancer Center - Garden City
- Central Care Cancer Center - Great Bend
- HaysMed University of Kansas Health System
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Olathe Health Cancer Center
- University of Kansas Cancer Center-Overland Park
- University of Kansas Hospital-Indian Creek Campus
- University of Kansas Hospital-Westwood Cancer Center
- Flaget Memorial Hospital
- Commonwealth Cancer Center-Corbin
- Saint Joseph Radiation Oncology Resource Center
- Saint Joseph Hospital EastRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Saint Joseph London
- Jewish Hospital
- Saints Mary and Elizabeth Hospital
- UofL Health Medical Center Northeast
- Jewish Hospital Medical Center South
- Ochsner LSU Health Monroe Medical CenterRecruiting
- Louisiana State University Health Science Center
- Tulane University Health Sciences Center
- University Medical Center New Orleans
- Ochsner LSU Health Saint Mary's Medical CenterRecruiting
- LSU Health Sciences Center at ShreveportRecruiting
- Massachusetts General Hospital Cancer CenterRecruiting
- Dana-Farber Cancer Institute
- Mercy Medical Center
- UMass Memorial Medical Center - University CampusRecruiting
- Hickman Cancer Center
- Saint Joseph Mercy HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Bronson Battle CreekRecruiting
- Saint Joseph Mercy BrightonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - BrightonRecruiting
- Henry Ford Cancer Institute-Downriver
- Saint Joseph Mercy CantonRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - CantonRecruiting
- Caro Cancer Center
- Saint Joseph Mercy ChelseaRecruiting
- Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalRecruiting
- Hematology Oncology Consultants-ClarkstonRecruiting
- Newland Medical Associates-ClarkstonRecruiting
- Henry Ford Macomb Hospital-Clinton Township
- Henry Ford Medical Center-Fairlane
- Henry Ford HospitalRecruiting
- Ascension Saint John HospitalRecruiting
- Great Lakes Cancer Management Specialists-Doctors ParkRecruiting
- Genesee Cancer and Blood Disease Treatment CenterRecruiting
- Genesee Hematology Oncology PCRecruiting
- Genesys Hurley Cancer InstituteRecruiting
- Hurley Medical CenterRecruiting
- Helen DeVos Children's Hospital at Spectrum Health
- Spectrum Health at Butterworth CampusRecruiting
- Trinity Health Grand Rapids HospitalRecruiting
- Academic Hematology Oncology SpecialistsRecruiting
- Great Lakes Cancer Management Specialists-Van Elslander Cancer CenterRecruiting
- Michigan Breast Specialists-Grosse Pointe Woods
- Allegiance Health
- Bronson Methodist HospitalRecruiting
- West Michigan Cancer CenterRecruiting
- Ascension Borgess Cancer CenterRecruiting
- Borgess Medical Center
- Sparrow Hospital
- Hope Cancer Clinic
- Trinity Health Saint Mary Mercy Livonia Hospital
- Great Lakes Cancer Management Specialists-Macomb Medical CampusRecruiting
- Michigan Breast Specialists-Macomb Township
- Saint Mary's Oncology/Hematology Associates of Marlette
- Toledo Clinic Cancer Centers-Monroe
- Trinity Health Muskegon HospitalRecruiting
- Lakeland Hospital Niles
- Cancer and Hematology Centers of Western Michigan - Norton ShoresRecruiting
- Ascension Providence Hospitals - NoviRecruiting
- Henry Ford Medical Center-Columbus
- 21st Century Oncology-PontiacRecruiting
- Hope Cancer Center
- Newland Medical Associates-PontiacRecruiting
- Saint Joseph Mercy OaklandRecruiting
- Spectrum Health Reed City Hospital
- Great Lakes Cancer Management Specialists-Rochester Hills
- Ascension Saint Mary's HospitalRecruiting
- Oncology Hematology Associates of Saginaw Valley PCRecruiting
- Lakeland Medical Center Saint Joseph
- Marie Yeager Cancer CenterRecruiting
- Henry Ford Macomb Health Center - Shelby Township
- Ascension Providence Hospitals - SouthfieldRecruiting
- Bhadresh Nayak MD PC-Sterling HeightsRecruiting
- Ascension Saint Joseph HospitalRecruiting
- Munson Medical Center
- Advanced Breast Care Center PLLCRecruiting
- Great Lakes Cancer Management Specialists-Macomb Professional BuildingRecruiting
- Macomb Hematology Oncology PC
- Michigan Breast Specialists-WarrenRecruiting
- Saint John Macomb-Oakland HospitalRecruiting
- Henry Ford West Bloomfield Hospital
- Saint Mary's Oncology/Hematology Associates of West BranchRecruiting
- University of Michigan Health - WestRecruiting
- Huron Gastroenterology PCRecruiting
- Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusRecruiting
- Fairview Ridges Hospital
- Minnesota Oncology - Burnsville
- Cambridge Medical Center
- Mercy Hospital
- Fairview Southdale HospitalRecruiting
- Unity Hospital
- Fairview Clinics and Surgery Center Maple Grove
- Minnesota Oncology Hematology PA-Maplewood
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Hennepin County Medical CenterRecruiting
- Health Partners Inc
- Monticello Cancer Center
- New Ulm Medical Center
- Fairview Northland Medical Center
- North Memorial Medical Health Center
- Mayo Clinic in RochesterRecruiting
- Coborn Cancer Center at Saint Cloud Hospital
- Park Nicollet Clinic - Saint Louis Park
- Regions Hospital
- United Hospital
- Saint Francis Regional Medical Center
- Lakeview Hospital
- Ridgeview Medical Center
- Rice Memorial Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Fairview Lakes Medical Center
- University of Mississippi Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-Ballwin
- Central Care Cancer Center - Bolivar
- Cox Cancer Center Branson
- MU Health - University Hospital/Ellis Fischel Cancer Center
- Siteman Cancer Center at West County Hospital
- Freeman Health System
- Mercy Hospital Joplin
- University of Kansas Cancer Center - North
- University of Kansas Cancer Center - Lee's Summit
- University of Kansas Cancer Center at North Kansas City Hospital
- Delbert Day Cancer Institute at PCRMC
- Mercy Clinic-Rolla-Cancer and Hematology
- Heartland Regional Medical Center
- Saint Louis Cancer and Breast Institute-South City
- Washington University School of Medicine
- Mercy Hospital South
- Siteman Cancer Center-South County
- Siteman Cancer Center at Christian Hospital
- Mercy Hospital Saint Louis
- Siteman Cancer Center at Saint Peters Hospital
- Mercy Hospital Springfield
- CoxHealth South Hospital
- Mercy Hospital Washington
- Community Hospital of AnacondaRecruiting
- Billings Clinic Cancer CenterRecruiting
- Bozeman Deaconess HospitalRecruiting
- Benefis Healthcare- Sletten Cancer InstituteRecruiting
- Great Falls Clinic
- Kalispell Regional Medical CenterRecruiting
- Saint Patrick Hospital - Community HospitalRecruiting
- Community Medical HospitalRecruiting
- CHI Health Saint Francis
- CHI Health Good SamaritanRecruiting
- Saint Elizabeth Regional Medical Center
- Alegent Health Immanuel Medical Center
- Alegent Health Bergan Mercy Medical Center
- Alegent Health Lakeside Hospital
- Creighton University Medical Center
- Midlands Community Hospital
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Morristown Medical Center
- Jersey Shore Medical CenterRecruiting
- Capital Health Medical Center-HopewellRecruiting
- Overlook HospitalRecruiting
- Lovelace Medical Center-Saint Joseph Square
- University of New Mexico Cancer Center
- Lovelace Radiation Oncology
- New York-Presbyterian/Brooklyn Methodist Hospital
- Arnot Ogden Medical Center/Falck Cancer Center
- Glens Falls HospitalRecruiting
- Northwell Health/Center for Advanced MedicineRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU Langone
- Lenox Hill HospitalRecruiting
- Manhattan Eye Ear and Throat HospitalRecruiting
- NYP/Weill Cornell Medical Center
- Upstate Cancer Center at Oneida
- University of RochesterRecruiting
- State University of New York Upstate Medical University
- UNC Lineberger Comprehensive Cancer CenterRecruiting
- Carolinas Medical Center/Levine Cancer InstituteRecruiting
- Atrium Health Pineville/LCI-PinevilleRecruiting
- Atrium Health Cabarrus/LCI-ConcordRecruiting
- Duke University Medical CenterRecruiting
- Margaret R Pardee Memorial HospitalRecruiting
- Vidant Oncology-KenansvilleRecruiting
- Vidant Oncology-KinstonRecruiting
- Vidant Oncology-RichlandsRecruiting
- UHHS-Chagrin Highlands Medical CenterRecruiting
- Miami Valley Hospital SouthRecruiting
- Geauga Hospital
- Good Samaritan Hospital - Cincinnati
- Bethesda North Hospital
- TriHealth Cancer Institute-Westside
- TriHealth Cancer Institute-Anderson
- Case Western Reserve UniversityRecruiting
- Ohio State University Comprehensive Cancer Center
- Dayton Blood and Cancer CenterRecruiting
- Miami Valley HospitalRecruiting
- Miami Valley Hospital NorthRecruiting
- Atrium Medical Center-Middletown Regional HospitalRecruiting
- UH Seidman Cancer Center at Lake Health Mentor CampusRecruiting
- UH Seidman Cancer Center at Southwest General HospitalRecruiting
- University Hospitals Parma Medical CenterRecruiting
- Mercy Health Perrysburg Cancer Center
- University Hospitals Portage Medical CenterRecruiting
- UH Seidman Cancer Center at Firelands Regional Medical CenterRecruiting
- Mercy Health - Saint Anne Hospital
- Toledo Clinic Cancer Centers-ToledoRecruiting
- Upper Valley Medical CenterRecruiting
- University Hospitals Sharon Health CenterRecruiting
- UH Seidman Cancer Center at Saint John Medical CenterRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma City
- Saint Alphonsus Medical Center-Baker City
- Saint Charles Health System
- Clackamas Radiation Oncology Center
- Providence Cancer Institute Clackamas Clinic
- Bay Area Hospital
- Providence Newberg Medical CenterRecruiting
- Saint Alphonsus Medical Center-OntarioRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Saint Vincent Medical CenterRecruiting
- Saint Charles Health System-Redmond
- Lehigh Valley Hospital-Cedar CrestRecruiting
- Saint Luke's Cancer Center - AllentownRecruiting
- Saint Luke's University Hospital-Bethlehem CampusRecruiting
- Lehigh Valley Hospital - MuhlenbergRecruiting
- Pocono Medical Center
- Saint Luke's Hospital-Anderson CampusRecruiting
- Lehigh Valley Hospital-Hazleton
- Pennsylvania HospitalRecruiting
- Thomas Jefferson University Hospital
- UPMC-Magee Womens Hospital
- University of Pittsburgh Cancer Institute (UPCI)
- Saint Luke's Hospital-Quakertown CampusRecruiting
- Saint Joseph Regional Cancer Center
- Parkland Memorial Hospital
- UT Southwestern/Simmons Cancer Center-Dallas
- UT Southwestern/Simmons Cancer Center-Fort Worth
- M D Anderson Cancer Center
- Memorial Hermann Texas Medical Center
- Memorial Hermann Northeast Hospital
- Memorial Hermann The Woodlands Hospital
- Huntsman Cancer Institute/University of UtahRecruiting
- Central Vermont Medical Center/National Life Cancer TreatmentRecruiting
- University of Vermont Medical CenterRecruiting
- University of Vermont and State Agricultural College
- Inova Schar Cancer Institute
- Inova Fair Oaks Hospital
- Bon Secours Saint Francis Medical CenterRecruiting
- Bon Secours Cancer Institute at Reynolds CrossingRecruiting
- Providence Regional Cancer System-Aberdeen
- PeaceHealth Saint Joseph Medical Center
- Harrison HealthPartners Hematology and Oncology-BremertonRecruiting
- Harrison Medical Center
- Highline Medical Center-Main Campus
- Providence Regional Cancer System-Centralia
- Swedish Cancer Institute-Edmonds
- Saint Elizabeth Hospital
- Providence Regional Cancer Partnership
- Saint Francis Hospital
- Swedish Cancer Institute-Issaquah
- Kadlec Clinic Hematology and OncologyRecruiting
- Providence Regional Cancer System-Lacey
- Saint Clare Hospital
- PeaceHealth Saint John Medical Center
- Harrison HealthPartners Hematology and Oncology-Poulsbo
- Pacific Gynecology Specialists
- Swedish Medical Center-Ballard Campus
- Swedish Medical Center-Cherry Hill
- Swedish Medical Center-First Hill
- PeaceHealth United General Medical Center
- Providence Regional Cancer System-Shelton
- Franciscan Research Center-Northwest Medical Plaza
- Northwest Medical Specialties PLLC
- PeaceHealth Southwest Medical CenterRecruiting
- Providence Saint Mary Regional Cancer Center
- Providence Regional Cancer System-Yelm
- Aurora Cancer Care-Southern Lakes VLCCRecruiting
- Aurora Saint Luke's South Shore
- Aurora Health Care Germantown Health CenterRecruiting
- Aurora Cancer Care-GraftonRecruiting
- Aurora BayCare Medical CenterRecruiting
- Aurora Cancer Care-Kenosha SouthRecruiting
- Aurora Bay Area Medical Group-MarinetteRecruiting
- Aurora Cancer Care-MilwaukeeRecruiting
- Aurora Saint Luke's Medical CenterRecruiting
- Medical College of Wisconsin
- Aurora Sinai Medical CenterRecruiting
- ProHealth D N Greenwald CenterRecruiting
- Cancer Center of Western Wisconsin
- ProHealth Oconomowoc Memorial HospitalRecruiting
- Vince Lombardi Cancer Clinic - OshkoshRecruiting
- Aurora Cancer Care-RacineRecruiting
- Vince Lombardi Cancer Clinic-SheboyganRecruiting
- Aurora Medical Center in SummitRecruiting
- Vince Lombardi Cancer Clinic-Two RiversRecruiting
- UW Cancer Center at ProHealth CareRecruiting
- Aurora Cancer Care-Milwaukee WestRecruiting
- Aurora West Allis Medical CenterRecruiting
- Billings Clinic-Cody
- Welch Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Arm I (CDK gene mutation)
Arm II (PI3K gene mutation)
Arm III (NTRK/ROS1 gene mutation)
Arm IV (KRAS G12C mutation)
Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive PI3K inhibitor paxalisib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients receive adagrasib (MRTX849) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.