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Active, not recruitingPhase 2

Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Key facts

Who runs it
Alliance for Clinical Trials in Oncology
Where
Aberdeen, Adrian, Albuquerque, Allentown, Alton, Ames, Anaconda, Anchorage, Ankeny, Ann Arbor, Arroyo Grande, Atlanta, Aurora, Baker City, Ballwin, Bardstown, Barrington, Battle Creek, Beachwood, Bellingham, Bend, Berlin Corners, Bethlehem, Billings, Boca Raton, Boise, Bolivar, Boone, Boston, Bozeman, Branson, Brighton, Brooklyn, Brownstown, Bryan, Burbank, Burien, Burlington, Burnsville, Caldwell, Cambridge, Canton, Caro, Carroll, Centerville, Centralia, Chapel Hill, Chardon, Charlotte, Chelsea, Chicago, Cincinnati, City of Saint Peters, Clackamas, Clarkston, Cleveland, Clinton Township, Clive, Cody, Coeur d'Alene, Colorado Springs, Columbia, Columbus, Concord, Coon Rapids, Coos Bay, Coral Gables, Corbin, Council Bluffs, Creston, Creve Coeur, Crystal Lake, Cudahy, Dallas, Danville, Dayton, Dearborn, Deerfield Beach, DeKalb, Delaware, Denver, Des Moines, Detroit, Downers Grove, Dublin, Durango, Durham, East China, East Stroudsburg, Easton, Edina, Edmonds, Effingham, Elgin, Elmira, Emeryville, Emmett, Enumclaw, Everett, Fairfax, Federal Way, Flint, Fort Dodge, Fort Lauderdale, Fort Smith, Fort Worth, Franklin, Fridley, Fruitland, Garden City, Geneva, Germantown, Glens Falls, Grafton, Grand Island, Grand Rapids, Great Bend, Great Falls, Green Bay, Greenville, Grosse Pointe Woods, Hays, Hazel Crest, Hazleton, Hendersonville, Hot Springs, Houston, Humble, Iowa City, Issaquah, Jackson, Jacksonville, Jefferson, Joplin, Kalamazoo, Kalispell, Kansas City, Kearney, Kenansville, Kennewick, Kenosha, Kinston, La Jolla, Lacey, Lake Forest, Lake Success, Lakewood, Lansing, Lawrence, Lebanon, Lee's Summit, Lexington, Lincoln, Littleton, Livonia, London, Longmont, Longview, Los Angeles, Louisville, Macomb, Mansfield, Maple Grove, Maplewood, Marinette, Marion, Marlette, Marshalltown, Martinez, Mattoon, Mentor, Meridian, Miami, Middleburg Heights, Midlothian, Milwaukee, Minneapolis, Missoula, Monroe, Monticello, Morristown, Mount Vernon, Mukwonago, Muskegon, Nampa, Neptune City, New Haven, New Orleans, New Richmond, New Ulm, New York, Newberg, Niles, North Kansas City, Norton Shores, Novi, Oak Lawn, Oakland, Oconomowoc, Oklahoma City, Olathe, Omaha, Ontario, Orange, Oregon City, Oshkosh, Overland Park, Papillion, Park Ridge, Parker, Parma, Pennington, Perrysburg, Philadelphia, Phoenix, Pittsburgh, Pontiac, Portland, Post Falls, Poulsbo, Princeton, Pueblo, Quakertown, Racine, Ravenna, Redmond, Reed City, Richlands, Richmond, Robbinsdale, Rochester, Rochester Hills, Rolla, Saginaw, Saint Cloud, Saint Joseph, Saint Louis Park, Saint Paul, Salt Lake City, San Diego, San Luis Obispo, Sandpoint, Sandusky, Santa Maria, Scottsdale, Seattle, Sedro-Woolley, Shakopee, Sheboygan, Shelby, Shelton, Shepherdsville, Sheridan, Shreveport, Silverdale, Southfield, Springfield, St Louis, Sterling Heights, Stillwater, Summit, Syracuse, Tacoma, Tawas City, The Woodlands, Toledo, Torrance, Traverse City, Troy, Twin Falls, Two Rivers, Urbana, Vancouver, Verona, Waconia, Wadsworth, Walla Walla, Walnut Creek, Warren, Warrenville, Washington, Waukee, Waukesha, Wauwatosa, West Allis, West Bloomfield, West Branch, West Chester, West Des Moines, Westlake, Westwood, Willmar, Woodbury, Worcester, Wyoming, Yelm, Yorkville, and Ypsilanti, United StatesSee the 435 sites
Trial code
Status
Active, not recruiting
Phase
Phase 2
People taking part
50 people enrolled
Started
17 Oct 2019
Expected to end
Jun 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Abemaciclib
  • PI3K Inhibitor paxalisib
  • Entrectinib
  • Adagrasib
Record updated
30 October 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 43 criteriaShow less

Who can take part

  • 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. Similarly, for patients with KRAS G12C mutations, MRTX849 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, KRAS G12C 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 for the CDK, PI3K and NTRK arms (diffuse defined as leptomeningeal involvement throughout the CNS axis).Patients with focal leptomeningeal disease, with or without documented positive CSF cytology, are eligible
  • 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 except for patients in the adagrasib (MRTX849) (KRAS G12C) arm. For this arm, patients must have creatinine clearance ≥60 mL/min or glomerular filtration rate ≥60 mL/min/1.73m2 calculated using a validated prediction equation (e.g., Cockcroft-Gault, MDRD, or 24-hour urine CrCl)
  • 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 for the PI3K and CDK inhibitor arms). . 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 or 5 or more half-lives 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; ADDITIONAL REGISTRATION ELIGIBILITY CRITERION FOR ADAGRASIB (MRTX849) ARM
  • Hemoglobin ≥9.0 g/dL. Note: Transfusions will be allowed to achieve this provided the patient has not received more than 2 units of red blood cells in the prior 4 weeks
  • Any of the following cardiovascular abnormalities within 6 months of study entry are excluded: symptomatic or uncontrolled atrial fibrillation, unstable angina pectoris or myocardial infarction, CHF ≥ NYHA Class 3, stroke or transient ischemic attack
  • Ongoing need for medication known to cause prolonged QTc interval or that are substrates of CYP3A4 with narrow therapeutic index that cannot be switched to alternative treatment prior to study entry is excluded
  • Prolonged QTc interval >480 milliseconds or family history or medical history of Long QT syndrome is excluded.•
  • Known human immunodeficiency virus (HIV) infection or acute or chronic hepatitis B or C infection is excluded. Screening is not required for enrollment. Note that the following are permitted:; Patients treated for hepatitis C (HCV) with no detectable viral load; Patients treated for HIV with no detectable viral load for at least 1 month prior to randomization while on a stable regimen of agents that are not strong inhibitors of CYP3A4; and; Patients with hepatitis B (HBV) receiving prophylaxis against reactivation of hepatitis B (either [HBsAg-positive with normal ALT and HBV DNA <2,000 IU/mL or <10,000 copies/mL] or [HBsAg-negative and anti-HBc positive])
  • History of intestinal disease or major gastric surgery likely to alter absorption of study treatment or inability to swallow oral medications is excluded
  • Recovery from the adverse effects of prior therapy to baseline or Grade 1 (any grade alopecia and Grade ≤2 peripheral neuropathy are eligible)
  • For females of childbearing potential. It is not known whether MRTX849 presents a risk to the embryo or the fetus; however, based on the mechanism of action (KRAS G12C inhibition), effects on the reproductive system are not unexpected. MRTX849 is contraindicated in women who are pregnant or lactating. Women of childbearing potential and men receiving MRTX849 who are sexually active must employ an effective method of contraception throughout their period of treatment and for 6 months after their last treatment with MRTX849

Where in United States

  • Providence Regional Cancer System-AberdeenAberdeen, United States
  • Hickman Cancer CenterAdrian, United States
  • Lovelace Medical Center-Saint Joseph SquareAlbuquerque, United States
  • Lovelace Radiation OncologyAlbuquerque, United States
  • University of New Mexico Cancer CenterAlbuquerque, United States
  • Lehigh Valley Hospital-Cedar CrestAllentown, United States
  • Saint Luke's Cancer Center - AllentownAllentown, United States
  • OSF Saint Anthony's Health CenterAlton, United States
  • Mary Greeley Medical CenterAmes, United States
  • McFarland Clinic - AmesAmes, United States
  • Community Hospital of AnacondaAnaconda, United States
  • Alaska Breast Care and Surgery LLCAnchorage, United States
  • Alaska Oncology and Hematology LLCAnchorage, United States
  • Alaska Women's Cancer CareAnchorage, United States
  • Anchorage Associates in Radiation MedicineAnchorage, United States
  • Anchorage Oncology CentreAnchorage, United States
  • Anchorage Radiation Therapy CenterAnchorage, United States
  • Katmai Oncology GroupAnchorage, United States
  • Providence Alaska Medical CenterAnchorage, United States
  • UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United States
  • Trinity Health Saint Joseph Mercy Hospital Ann ArborAnn Arbor, United States
  • University of Michigan Rogel Cancer CenterAnn Arbor, United States
  • Mission Hope Medical Oncology - Arroyo GrandeArroyo Grande, United States
  • Emory Saint Joseph's HospitalAtlanta, United States
  • Emory University Hospital MidtownAtlanta, United States
  • Emory University Hospital/Winship Cancer InstituteAtlanta, United States
  • Rush-Copley Medical CenterAurora, United States
  • Saint Alphonsus Cancer Care Center-Baker CityBaker City, United States
  • Mercy Oncology and Hematology - Clayton-ClarksonBallwin, United States
  • Flaget Memorial HospitalBardstown, United States
  • Advocate Good Shepherd HospitalBarrington, United States
  • Bronson Battle CreekBattle Creek, United States
  • UHHS-Chagrin Highlands Medical CenterBeachwood, United States
  • PeaceHealth Saint Joseph Medical CenterBellingham, United States
  • Saint Charles Health SystemBend, United States
  • Central Vermont Medical Center/National Life Cancer TreatmentBerlin Corners, United States
  • Lehigh Valley Hospital - MuhlenbergBethlehem, United States
  • Saint Luke's University Hospital-Bethlehem CampusBethlehem, United States
  • Billings Clinic Cancer CenterBillings, United States
  • Boca Raton Regional HospitalBoca Raton, United States
  • Saint Alphonsus Cancer Care Center-BoiseBoise, United States
  • Saint Luke's Cancer Institute - BoiseBoise, United States
  • Central Care Cancer Center - BolivarBolivar, United States
  • McFarland Clinic - BooneBoone, United States
  • Dana-Farber Cancer InstituteBoston, United States
  • Massachusetts General Hospital Cancer CenterBoston, United States
  • Bozeman Health Deaconess HospitalBozeman, United States
  • Cox Cancer Center BransonBranson, United States
  • Trinity Health IHA Medical Group Hematology Oncology - BrightonBrighton, United States
  • Trinity Health Medical Center - BrightonBrighton, United States
  • University of Michigan - Brighton Center for Specialty CareBrighton, United States
  • New York-Presbyterian/Brooklyn Methodist HospitalBrooklyn, United States
  • Henry Ford Cancer Institute-DownriverBrownstown, United States
  • Saint Joseph Regional Cancer CenterBryan, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer CenterBurbank, United States
  • Highline Medical Center-Main CampusBurien, United States
  • Aurora Cancer Care-Southern Lakes VLCCBurlington, United States
  • University of Vermont and State Agricultural CollegeBurlington, United States
  • University of Vermont Medical CenterBurlington, United States
  • Fairview Ridges HospitalBurnsville, United States
  • Minnesota Oncology - BurnsvilleBurnsville, United States
  • Saint Alphonsus Cancer Care Center-CaldwellCaldwell, United States
  • Cambridge Medical CenterCambridge, United States
  • Trinity Health IHA Medical Group Hematology Oncology - CantonCanton, United States
  • Trinity Health Medical Center - CantonCanton, United States
  • Caro Cancer CenterCaro, United States
  • Saint Anthony Regional HospitalCarroll, United States
  • Miami Valley Hospital SouthCenterville, United States
  • Providence Regional Cancer System-CentraliaCentralia, United States
  • UNC Lineberger Comprehensive Cancer CenterChapel Hill, United States
  • Geauga HospitalChardon, United States
  • Atrium Health Pineville/LCI-PinevilleCharlotte, United States
  • Carolinas Medical Center/Levine Cancer InstituteCharlotte, United States
  • Chelsea HospitalChelsea, United States
  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea HospitalChelsea, United States
  • Advocate Illinois Masonic Medical CenterChicago, United States
  • Northwestern UniversityChicago, United States
  • Rush MD Anderson Cancer CenterChicago, United States
  • University of IllinoisChicago, United States
  • Bethesda North HospitalCincinnati, United States
  • Good Samaritan Hospital - CincinnatiCincinnati, United States
  • TriHealth Cancer Institute-AndersonCincinnati, United States
  • TriHealth Cancer Institute-WestsideCincinnati, United States
  • University of Cincinnati Cancer Center-UC Medical CenterCincinnati, United States
  • Siteman Cancer Center at Saint Peters HospitalCity of Saint Peters, United States
  • Clackamas Radiation Oncology CenterClackamas, United States
  • Providence Cancer Institute Clackamas ClinicClackamas, United States
  • Hematology Oncology Consultants-ClarkstonClarkston, United States
  • Newland Medical Associates-ClarkstonClarkston, United States
  • Case Western Reserve UniversityCleveland, United States
  • Henry Ford Macomb Hospital-Clinton TownshipClinton Township, United States
  • Mercy Cancer Center-West LakesClive, United States
  • UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United States
  • Billings Clinic-CodyCody, United States
  • Kootenai Health - Coeur d'AleneCoeur d'Alene, United States
  • Penrose-Saint Francis HealthcareColorado Springs, United States
  • Rocky Mountain Cancer Centers-PenroseColorado Springs, United States
  • MU Health - University Hospital/Ellis Fischel Cancer CenterColumbia, United States
  • Columbus Oncology and Hematology Associates IncColumbus, United States
  • Doctors HospitalColumbus, United States
  • Grant Medical CenterColumbus, United States
  • Ohio State University Comprehensive Cancer CenterColumbus, United States
  • Riverside Methodist HospitalColumbus, United States
  • Atrium Health Cabarrus/LCI-ConcordConcord, United States
  • Mercy HospitalCoon Rapids, United States
  • Bay Area HospitalCoos Bay, United States
  • UM Sylvester Comprehensive Cancer Center at Coral GablesCoral Gables, United States
  • Commonwealth Cancer Center-CorbinCorbin, United States
  • Alegent Health Mercy HospitalCouncil Bluffs, United States
  • Greater Regional Medical CenterCreston, United States
  • Siteman Cancer Center at West County HospitalCreve Coeur, United States
  • AMG Crystal Lake - OncologyCrystal Lake, United States
  • Aurora Saint Luke's South ShoreCudahy, United States
  • Parkland Memorial HospitalDallas, United States
  • UT Southwestern/Simmons Cancer Center-DallasDallas, United States
  • Carle at The RiverfrontDanville, United States
  • Miami Valley HospitalDayton, United States
  • Miami Valley Hospital NorthDayton, United States
  • Premier Blood and Cancer CenterDayton, United States
  • Henry Ford Medical Center-FairlaneDearborn, United States
  • UM Sylvester Comprehensive Cancer Center at Deerfield BeachDeerfield Beach, United States
  • Northwestern Medicine Cancer Center KishwaukeeDeKalb, United States
  • Delaware Health Center-Grady Cancer CenterDelaware, United States
  • Grady Memorial HospitalDelaware, United States
  • AdventHealth PorterDenver, United States
  • Broadlawns Medical CenterDes Moines, United States
  • Iowa Lutheran HospitalDes Moines, United States
  • Iowa Methodist Medical CenterDes Moines, United States
  • Mercy Medical Center - Des MoinesDes Moines, United States
  • UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United States
  • UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United States
  • Henry Ford Health Saint John HospitalDetroit, United States
  • Henry Ford HospitalDetroit, United States
  • Advocate Good Samaritan HospitalDowners Grove, United States
  • Columbus Oncology and Hematology AssociatesDublin, United States
  • Dublin Methodist HospitalDublin, United States
  • Epic Care-DublinDublin, United States
  • CommonSpirit Cancer Center MercyDurango, United States
  • Mercy Medical CenterDurango, United States
  • Duke University Medical CenterDurham, United States
  • Henry Ford River District HospitalEast China, United States
  • Pocono Medical CenterEast Stroudsburg, United States
  • Saint Luke's Hospital-Anderson CampusEaston, United States
  • Fairview Southdale HospitalEdina, United States
  • Swedish Cancer Institute-EdmondsEdmonds, United States
  • Carle Physician Group-EffinghamEffingham, United States
  • Advocate Sherman HospitalElgin, United States
  • Arnot Ogden Medical Center/Falck Cancer CenterElmira, United States
  • Bay Area Breast Surgeons IncEmeryville, United States
  • Epic Care Partners in Cancer CareEmeryville, United States
  • Walter Knox Memorial HospitalEmmett, United States
  • Saint Elizabeth HospitalEnumclaw, United States
  • Providence Regional Cancer PartnershipEverett, United States
  • Inova Fair Oaks HospitalFairfax, United States
  • Inova Schar Cancer InstituteFairfax, United States
  • Saint Francis HospitalFederal Way, United States
  • Cancer Hematology Centers - FlintFlint, United States
  • Genesee Hematology Oncology PCFlint, United States
  • Genesys Hurley Cancer InstituteFlint, United States
  • Hurley Medical CenterFlint, United States
  • McFarland Clinic - Trinity Cancer CenterFort Dodge, United States
  • UI Healthcare Mission Cancer and Blood - Fort DodgeFort Dodge, United States
  • Holy Cross HospitalFort Lauderdale, United States
  • Mercy Hospital Fort SmithFort Smith, United States
  • UT Southwestern/Simmons Cancer Center-Fort WorthFort Worth, United States
  • Atrium Medical Center-Middletown Regional HospitalFranklin, United States
  • Unity HospitalFridley, United States
  • Saint Luke's Cancer Institute - FruitlandFruitland, United States
  • Central Care Cancer Center - Garden CityGarden City, United States
  • Northwestern Medicine Cancer Center DelnorGeneva, United States
  • Aurora Health Care Germantown Health CenterGermantown, United States
  • Glens Falls HospitalGlens Falls, United States
  • Aurora Cancer Care-GraftonGrafton, United States
  • Nebraska Cancer Specialists/Oncology Hematology West PCGrand Island, United States
  • Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United States
  • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's HospitalGrand Rapids, United States
  • Trinity Health Grand Rapids HospitalGrand Rapids, United States
  • Central Care Cancer Center - Great BendGreat Bend, United States
  • Benefis Sletten Cancer InstituteGreat Falls, United States
  • Great Falls ClinicGreat Falls, United States
  • Aurora BayCare Medical CenterGreen Bay, United States
  • Miami Valley Cancer Care and InfusionGreenville, United States
  • Henry Ford Saint John Hospital - AcademicGrosse Pointe Woods, United States
  • Henry Ford Saint John Hospital - BreastGrosse Pointe Woods, United States
  • Henry Ford Saint John Hospital - Van ElslanderGrosse Pointe Woods, United States
  • HaysMedHays, United States
  • Advocate South Suburban HospitalHazel Crest, United States
  • Lehigh Valley Hospital-HazletonHazleton, United States
  • Margaret R Pardee Memorial HospitalHendersonville, United States
  • CHI Saint Vincent Cancer Center Hot SpringsHot Springs, United States
  • Memorial Hermann Texas Medical CenterHouston, United States
  • Memorial Hermann Northeast HospitalHumble, United States
  • University of Iowa/Holden Comprehensive Cancer CenterIowa City, United States
  • Swedish Cancer Institute-IssaquahIssaquah, United States
  • Allegiance HealthJackson, United States
  • University of Mississippi Medical CenterJackson, United States
  • Mayo Clinic in FloridaJacksonville, United States
  • McFarland Clinic - JeffersonJefferson, United States
  • Freeman Health SystemJoplin, United States
  • Mercy Hospital JoplinJoplin, United States
  • Beacon KalamazooKalamazoo, United States
  • Beacon Kalamazoo Cancer CenterKalamazoo, United States
  • Bronson Methodist HospitalKalamazoo, United States
  • West Michigan Cancer CenterKalamazoo, United States
  • Logan Health Medical CenterKalispell, United States
  • University of Kansas Cancer CenterKansas City, United States
  • University of Kansas Cancer Center - NorthKansas City, United States
  • CHI Health Good SamaritanKearney, United States
  • ECU Health Oncology KenansvilleKenansville, United States
  • Kadlec Clinic Hematology and OncologyKennewick, United States
  • Aurora Cancer Care-Kenosha SouthKenosha, United States
  • ECU Health Oncology KinstonKinston, United States
  • UC San Diego Moores Cancer CenterLa Jolla, United States
  • Providence Regional Cancer System-LaceyLacey, United States
  • Northwestern Medicine Lake Forest HospitalLake Forest, United States
  • Northwell Health/Center for Advanced MedicineLake Success, United States
  • Saint Anthony HospitalLakewood, United States
  • Saint Clare HospitalLakewood, United States
  • University of Michigan Health - Sparrow LansingLansing, United States
  • Lawrence Memorial HospitalLawrence, United States
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterLebanon, United States
  • University of Kansas Cancer Center - Lee's SummitLee's Summit, United States
  • Saint Joseph Hospital EastLexington, United States
  • Saint Joseph Radiation Oncology Resource CenterLexington, United States
  • University of Kentucky/Markey Cancer CenterLexington, United States
  • Saint Elizabeth Regional Medical CenterLincoln, United States
  • AdventHealth LittletonLittleton, United States
  • Hope Cancer ClinicLivonia, United States
  • Trinity Health Saint Mary Mercy Livonia HospitalLivonia, United States
  • Saint Joseph LondonLondon, United States
  • Longmont United HospitalLongmont, United States
  • Rocky Mountain Cancer Centers-LongmontLongmont, United States
  • PeaceHealth Saint John Medical CenterLongview, United States
  • Cedars-Sinai Medical CenterLos Angeles, United States
  • Jewish HospitalLouisville, United States
  • Saints Mary and Elizabeth HospitalLouisville, United States
  • UofL Health Medical Center NortheastLouisville, United States
  • Henry Ford Saint John Hospital - Macomb MedicalMacomb, United States
  • Henry Ford Warren Hospital - Breast MacombMacomb, United States
  • OhioHealth Mansfield HospitalMansfield, United States
  • Fairview Clinics and Surgery Center Maple GroveMaple Grove, United States
  • Minnesota Oncology Hematology PA-MaplewoodMaplewood, United States
  • Saint John's Hospital - HealtheastMaplewood, United States
  • Aurora Bay Area Medical Group-MarinetteMarinette, United States
  • OhioHealth Marion General HospitalMarion, United States
  • Saint Mary's Oncology/Hematology Associates of MarletteMarlette, United States
  • McFarland Clinic - MarshalltownMarshalltown, United States
  • Contra Costa Regional Medical CenterMartinez, United States
  • Carle Physician Group-Mattoon/CharlestonMattoon, United States
  • UH Seidman Cancer Center at Lake Health Mentor CampusMentor, United States
  • Idaho Urologic Institute-MeridianMeridian, United States
  • Saint Luke's Cancer Institute - MeridianMeridian, United States
  • University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, United States
  • UH Seidman Cancer Center at Southwest General HospitalMiddleburg Heights, United States
  • Bon Secours Saint Francis Medical CenterMidlothian, United States
  • Aurora Cancer Care-MilwaukeeMilwaukee, United States
  • Aurora Saint Luke's Medical CenterMilwaukee, United States
  • Aurora Sinai Medical CenterMilwaukee, United States
  • Medical College of WisconsinMilwaukee, United States
  • Abbott-Northwestern HospitalMinneapolis, United States
  • Health Partners IncMinneapolis, United States
  • Hennepin County Medical CenterMinneapolis, United States
  • Community Medical CenterMissoula, United States
  • Saint Patrick Hospital - Community HospitalMissoula, United States
  • Ochsner LSU Health Monroe Medical CenterMonroe, United States
  • Toledo Clinic Cancer Centers-MonroeMonroe, United States
  • Monticello Cancer CenterMonticello, United States
  • Morristown Medical CenterMorristown, United States
  • SSM Health Good SamaritanMount Vernon, United States
  • ProHealth D N Greenwald CenterMukwonago, United States
  • Trinity Health Muskegon HospitalMuskegon, United States
  • Saint Alphonsus Cancer Care Center-NampaNampa, United States
  • Saint Luke's Cancer Institute - NampaNampa, United States
  • Jersey Shore Medical CenterNeptune City, United States
  • Smilow Cancer Center/Yale-New Haven HospitalNew Haven, United States
  • Yale UniversityNew Haven, United States
  • Louisiana State University Health Science CenterNew Orleans, United States
  • Tulane University School of MedicineNew Orleans, United States
  • University Medical Center New OrleansNew Orleans, United States
  • Cancer Center of Western WisconsinNew Richmond, United States
  • New Ulm Medical CenterNew Ulm, United States
  • Laura and Isaac Perlmutter Cancer Center at NYU LangoneNew York, United States
  • Lenox Hill HospitalNew York, United States
  • Manhattan Eye Ear and Throat HospitalNew York, United States
  • NYP/Weill Cornell Medical CenterNew York, United States
  • Providence Newberg Medical CenterNewberg, United States
  • Corewell Health Lakeland Hospitals - Niles HospitalNiles, United States
  • University of Kansas Cancer Center at North Kansas City HospitalNorth Kansas City, United States
  • Cancer and Hematology Centers of Western Michigan - Norton ShoresNorton Shores, United States
  • Henry Ford Health Providence Novi HospitalNovi, United States
  • Henry Ford Medical Center-ColumbusNovi, United States
  • Advocate Christ Medical CenterOak Lawn, United States
  • Alta Bates Summit Medical Center - Summit CampusOakland, United States
  • Bay Area Tumor InstituteOakland, United States
  • ProHealth Oconomowoc Memorial HospitalOconomowoc, United States
  • Mercy Hospital Oklahoma CityOklahoma City, United States
  • University of Oklahoma Health Sciences CenterOklahoma City, United States
  • The University of Kansas Cancer Center - OlatheOlathe, United States
  • Alegent Health Bergan Mercy Medical CenterOmaha, United States
  • Alegent Health Immanuel Medical CenterOmaha, United States
  • Alegent Health Lakeside HospitalOmaha, United States
  • Creighton University Medical CenterOmaha, United States
  • Saint Alphonsus Cancer Care Center-OntarioOntario, United States
  • UC Irvine Health- Chao Family Comprehensive Cancer CenterOrange, United States
  • Providence Willamette Falls Medical CenterOregon City, United States
  • Vince Lombardi Cancer Clinic - OshkoshOshkosh, United States
  • University of Kansas Cancer Center-Overland ParkOverland Park, United States
  • University of Kansas Hospital-Indian Creek CampusOverland Park, United States
  • Midlands Community HospitalPapillion, United States
  • Advocate Lutheran General HospitalPark Ridge, United States
  • AdventHealth ParkerParker, United States
  • University Hospitals Parma Medical CenterParma, United States
  • Capital Health Medical Center-HopewellPennington, United States
  • Mercy Health - Perrysburg HospitalPerrysburg, United States
  • Pennsylvania HospitalPhiladelphia, United States
  • Thomas Jefferson University HospitalPhiladelphia, United States
  • Cancer Center at Saint Joseph'sPhoenix, United States
  • Mayo Clinic Hospital in ArizonaPhoenix, United States
  • University of Pittsburgh Cancer Institute (UPCI)Pittsburgh, United States
  • UPMC-Magee Womens HospitalPittsburgh, United States
  • Hope Cancer CenterPontiac, United States
  • Michigan Healthcare Professionals PontiacPontiac, United States
  • Newland Medical Associates-PontiacPontiac, United States
  • Trinity Health Saint Joseph Mercy Oakland HospitalPontiac, United States
  • Providence Portland Medical CenterPortland, United States
  • Providence Saint Vincent Medical CenterPortland, United States
  • Kootenai Clinic Cancer Services - Post FallsPost Falls, United States
  • Harrison HealthPartners Hematology and Oncology-PoulsboPoulsbo, United States
  • Fairview Northland Medical CenterPrinceton, United States
  • Saint Mary Corwin Medical CenterPueblo, United States
  • Saint Luke's Hospital-Quakertown CampusQuakertown, United States
  • Aurora Cancer Care-RacineRacine, United States
  • University Hospitals Portage Medical CenterRavenna, United States
  • Saint Charles Health System-RedmondRedmond, United States
  • Corewell Health Reed City HospitalReed City, United States
  • ECU Health Oncology RichlandsRichlands, United States
  • Bon Secours Cancer Institute at Reynolds CrossingRichmond, United States
  • North Memorial Medical Health CenterRobbinsdale, United States
  • Mayo Clinic in RochesterRochester, United States
  • University of RochesterRochester, United States
  • Henry Ford Rochester HospitalRochester Hills, United States
  • Mercy Clinic-Rolla-Cancer and HematologyRolla, United States
  • Phelps Health Delbert Day Cancer InstituteRolla, United States
  • MyMichigan Medical Center SaginawSaginaw, United States
  • Oncology Hematology Associates of Saginaw Valley PCSaginaw, United States
  • Coborn Cancer Center at Saint Cloud HospitalSaint Cloud, United States
  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer CenterSaint Joseph, United States
  • Corewell Health Lakeland Hospitals - Saint Joseph HospitalSaint Joseph, United States
  • Heartland Regional Medical CenterSaint Joseph, United States
  • Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United States
  • Regions HospitalSaint Paul, United States
  • United HospitalSaint Paul, United States
  • Huntsman Cancer Institute/University of UtahSalt Lake City, United States
  • Sharp Memorial HospitalSan Diego, United States
  • Pacific Central Coast Health Center-San Luis ObispoSan Luis Obispo, United States
  • Kootenai Clinic Cancer Services - SandpointSandpoint, United States
  • UH Seidman Cancer Center at Firelands Regional Medical CenterSandusky, United States
  • Mission Hope Medical Oncology - Santa MariaSanta Maria, United States
  • Mayo Clinic in ArizonaScottsdale, United States
  • Pacific Gynecology SpecialistsSeattle, United States
  • Swedish Medical Center-Ballard CampusSeattle, United States
  • Swedish Medical Center-Cherry HillSeattle, United States
  • Swedish Medical Center-First HillSeattle, United States
  • PeaceHealth United General Medical CenterSedro-Woolley, United States
  • Saint Francis Regional Medical CenterShakopee, United States
  • Vince Lombardi Cancer Clinic-SheboyganSheboygan, United States
  • Henry Ford Macomb Health Center - Shelby TownshipShelby, United States
  • Providence Regional Cancer System-SheltonShelton, United States
  • Jewish Hospital Medical Center SouthShepherdsville, United States
  • Welch Cancer CenterSheridan, United States
  • LSU Health Sciences Center at ShreveportShreveport, United States
  • Ochsner LSU Health Saint Mary's Medical CenterShreveport, United States
  • Saint Michael Cancer CenterSilverdale, United States
  • Henry Ford Health Providence Southfield HospitalSouthfield, United States
  • CoxHealth South HospitalSpringfield, United States
  • Mercy Hospital SpringfieldSpringfield, United States
  • Mercy Medical CenterSpringfield, United States
  • Mercy Hospital Saint LouisSt Louis, United States
  • Mercy Hospital SouthSt Louis, United States
  • Mercy Infusion Center - ChippewaSt Louis, United States
  • Siteman Cancer Center at Christian HospitalSt Louis, United States
  • Siteman Cancer Center-South CountySt Louis, United States
  • Washington University School of MedicineSt Louis, United States
  • Bhadresh Nayak MD PC-Sterling HeightsSterling Heights, United States
  • Lakeview HospitalStillwater, United States
  • Aurora Medical Center in SummitSummit, United States
  • Overlook HospitalSummit, United States
  • State University of New York Upstate Medical UniversitySyracuse, United States
  • Franciscan Research Center-Northwest Medical PlazaTacoma, United States
  • Northwest Medical Specialties PLLCTacoma, United States
  • MyMichigan Medical Center TawasTawas City, United States
  • Memorial Hermann The Woodlands HospitalThe Woodlands, United States
  • Mercy Health - Saint Anne HospitalToledo, United States
  • Toledo Clinic Cancer Centers-ToledoToledo, United States
  • Torrance Memorial Medical CenterTorrance, United States
  • Torrance Memorial Physician Network - Cancer CareTorrance, United States
  • Munson Medical CenterTraverse City, United States
  • Upper Valley Medical CenterTroy, United States
  • Saint Luke's Cancer Institute - Twin FallsTwin Falls, United States
  • Vince Lombardi Cancer Clinic-Two RiversTwo Rivers, United States
  • Carle Cancer CenterUrbana, United States
  • The Carle Foundation HospitalUrbana, United States
  • PeaceHealth Southwest Medical CenterVancouver, United States
  • Upstate Cancer Center at VeronaVerona, United States
  • Ridgeview Medical CenterWaconia, United States
  • University Hospitals Sharon Health CenterWadsworth, United States
  • Providence Saint Mary Regional Cancer CenterWalla Walla, United States
  • Epic Care Cyberknife CenterWalnut Creek, United States
  • Advanced Breast Care Center PLLCWarren, United States
  • Henry Ford Health Warren HospitalWarren, United States
  • Henry Ford Madison Heights Hospital - BreastWarren, United States
  • Henry Ford Warren Hospital - GLCMSWarren, United States
  • Macomb Hematology Oncology PCWarren, United States
  • Northwestern Medicine Cancer Center WarrenvilleWarrenville, United States
  • Mercy Hospital WashingtonWashington, United States
  • UI Health Care Mission Cancer and Blood - Waukee ClinicWaukee, United States
  • UW Cancer Center at ProHealth CareWaukesha, United States
  • Aurora Cancer Care-Milwaukee WestWauwatosa, United States
  • Aurora West Allis Medical CenterWest Allis, United States
  • Henry Ford West Bloomfield HospitalWest Bloomfield, United States
  • Saint Mary's Oncology/Hematology Associates of West BranchWest Branch, United States
  • University of Cincinnati Cancer Center-West ChesterWest Chester, United States
  • Mercy Medical Center-West LakesWest Des Moines, United States
  • Methodist West HospitalWest Des Moines, United States
  • UH Seidman Cancer Center at Saint John Medical CenterWestlake, United States
  • University of Kansas Hospital-Westwood Cancer CenterWestwood, United States
  • Rice Memorial HospitalWillmar, United States
  • Minnesota Oncology Hematology PA-WoodburyWoodbury, United States
  • UMass Memorial Medical Center - University CampusWorcester, United States
  • Fairview Lakes Medical CenterWyoming, United States
  • University of Michigan Health - WestWyoming, United States
  • Providence Regional Cancer System-YelmYelm, United States
  • Rush-Copley Healthcare CenterYorkville, United States
  • Huron Gastroenterology PCYpsilanti, United States
  • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor CampusYpsilanti, United States

About the trial

What the trial wants to find out

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, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib 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.

The 4 groups in the trial

  • Arm I (CDK gene mutation)Treatment being tested

    Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Treatment: Abemaciclib

  • Arm II (PI3K gene mutation)Treatment being tested

    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.

    Treatment: PI3K Inhibitor paxalisib

  • Arm III (NTRK/ROS1 gene mutation)Treatment being tested

    Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Treatment: Entrectinib

  • Arm IV (KRAS G12C mutation)Treatment being tested

    Patients receive adagrasib (MRTX849) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

    Treatment: Adagrasib

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Genomically-Guided Treatment Trial in Brain Metastases
Record updated
30 October 2026