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Genetic Testing in Guiding Treatment for Patients With Brain Metastases

StatusActive, Not Recruiting
PhasePhase 2
Started2019-10-17
View on ClinicalTrials.gov ↗

Amendment history

The 49 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-29
Primary completion confirmed: November 2025 (last estimated October 2026)
2026-04-09
Suspended→Active, Not Recruiting Study Status, Study Design v52
Trial statusSuspended→Active, Not Recruiting
Reason stoppedInterim analysis→not stated
Enrollment targetestimated 186→confirmed 50
2026-03-02
Study Status, Contacts/Locations v51
Study sites435 entries, revised
UniversityMayo ofClinic Chicagoin Comprehensive Cancer CenterArizona
2026-02-03
Study Status v50
Re-verified, no change to tracked fields
2026-01-06
Study Status, Contacts/Locations v49
Study sites435 entries, revised
University of Michigan ComprehensiveRogel Cancer Center
Show 45 earlier versions
2025-12-08
Study Status v48
Re-verified, no change to tracked fields
2025-11-04
Study Status, Contacts/Locations v47
Study sites435 entries, revised
Rush UniversityMD MedicalAnderson Cancer Center
2025-10-07
Study Status v46
Re-verified, no change to tracked fields
2025-09-05
Recruiting→Suspended Study Status, Contacts/Locations v45
Trial statusRecruiting→Suspended
Reason stoppednot stated→Interim analysis
Study sites437→435
2025-06-24
Study Status, Contacts/Locations v44
Study sitesdetails revised at 7 of 437 sites
2025-03-28
Study Identification, Study Status, Oversight, Contacts/Locations v43
Study sites437 entries, revised
AdventHealth Porter AdventHealth AdventistLittleton AdventHealth HospitalParker LittletonSSM AdventistHealth Hospital Parker Adventist Hospital Good Samaritan Regional UI Health Center Care Mission Cancer and Blood - Ankeny Clinic UI Health Care Mission Cancer and Blood - West Des Moines Clinic UI Health Care Mission Cancer and Blood - Des Moines Clinic UI Health Care Mission Cancer and Blood - Laurel Clinic UI Health Care Mission Cancer and Blood - Waukee Clinic Phelps Health Delbert Day Cancer Institute at PCRMC Harrison HealthPartners Hematology and Oncology-Bremerton
Study titlerevised
Genetic Testing in Guiding Treatment for Patients withWith Brain Metastases
2025-01-13
Study Identification, Study Status, Oversight, Contacts/Locations v42
Primary completion date2025-10→2026-10
Completion date2026-06→2028-06
Start date2019-08-15→2019-10-17
Study sitesdetails revised at 178 of 437 sites
Study titlerevised
Genetic Testing in Guiding Treatment for Patients Withwith Brain Metastases
2024-12-24
Study Status, Contacts/Locations v41
Primary completion date2024-10→2025-10
Completion date2025-06→2026-06
Study sites426→437
2024-10-24
Study Status, Contacts/Locations v40
Study sites426 entries, revised
AscensionHenry Ford Health Saint John Hospital Henry Ford Saint John Hospital - Academic Henry HematologyFord OncologySaint SpecialistsJohn Hospital - Breast MichiganHenry Ford Warren Hospital - Breast Specialists-GrosseMacomb Henry PointeFord Woods Michigan Breast Specialists-Macomb Township AscensionHealth Providence HospitalsNovi Hospital MyMichigan Medical Center Saginaw Henry Ford Health Providence Southfield Hospital MyMichigan Medical Center Tawas Henry Ford Madison Heights Hospital - Novi Ascension Saint Mary's Hospital Ascension Providence Hospitals - Southfield Ascension Saint Joseph [...] [...]
2024-08-01
Study Status, Contacts/Locations v39
Study sites426 entries, revised
Kootenai Clinic Cancer ClinicServices - Sandpoint SaintChelsea JosephHospital ECU Mercy Chelsea VidantHealth Oncology- Kenansville VidantECU Health Oncology- Richlands Saint Alphonsus MedicalCancer Care Center-Baker City Saint Alphonsus MedicalCancer Care Center-Ontario
2024-05-22
Study Status, Contacts/Locations v38
Study sites424→426
2024-04-08
Study Status, Contacts/Locations v37
Study sites424 entries, revised
University of Michigan Health - Sparrow HospitalLansing
2024-02-19
Study Status, Contacts/Locations v36
Study sites417→424
2023-10-30
Study Status, Contacts/Locations v35
Study sites416→417
2023-08-30
Study Status, Contacts/Locations v34
Study sites405→416
2023-07-11
Study Status, Sponsor/Collaborators, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility v33
Enrollment target150→186
Study arms3→4
InterventionsAbemaciclib (Drug), Entrectinib (Drug), PI3K Inhibitor paxalisib (Drug)→Abemaciclib (Drug), Adagrasib (Drug), Entrectinib (Drug), PI3K Inhibitor paxalisib (Drug)
Eligibility criteria+2,841 characters
[...] trectinib 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 r [...] Presence of clinically actionable alteration in NTRK, ROS1, KRAS G12C or CDK pathway or PI3K pathway in both a brain metastasis a [...] ration). No known current diffuse leptomeningeal involvement for the CDK, PI3K and NTRK arms (diffuse defined as leptomeningeal involvement throughout the CNS axis;).Patients ifwith therefocal isleptomeningeal disease, with or without documen [...] [...]
Study description+402 characters
[...] gene fusions as measured by response rate (RANO criteria). IV. To determine the activity of an KRAS G12C inhibitor in patients with progressive brain metastases derived from lung cancer, and other cancers harboring a KRAS G12C mutation as measured by response rate (RANO criteria). SECONDARY OBJECTIVES: I. To evaluate the systemic response b [...] primary cancer type. OUTLINE: Patients are assigned to 1 of 34 arms. ARM I (CDK GENE MUTATION): Patients receive abemacicl [...] he absence of disease progression or unacceptable toxicity. ARM IV (KRAS G12C MUTATION): Patients receive adagrasib (MRTX849) PO BID on [...] [...]
Collaborators2 to 5 entries
Mirati Therapeutics Inc. Eli Lilly and Company Kazia Therapeutics Limited
2023-04-03
Study Status, Contacts/Locations v32
Study sites387→405
2022-06-03
Study Status, Contacts/Locations v31
Study sites386→387
2022-04-18
Study Status, Contacts/Locations v30
Study sitesdetails revised at 5 of 386 sites
2022-03-22
Study Status, Contacts/Locations v29
Study sitesdetails revised at 18 of 386 sites
2022-02-16
Study Status, Contacts/Locations v28
Study sites380→386
2022-01-11
Study Status, Contacts/Locations v27
Study sitesdetails revised at 50 of 380 sites
2021-12-13
Study Status, Contacts/Locations v26
Study sitesdetails revised at 17 of 380 sites
2021-11-11
Study Status, Contacts/Locations v25
Study sites379→380
2021-10-11
Study Status, Contacts/Locations v24
Study sitesdetails revised at 189 of 379 sites
2021-08-16
Study Status, Contacts/Locations v23
Study sitesdetails revised at 14 of 379 sites
2021-07-19
Study Status, Contacts/Locations v22
Study sites369→379
2021-06-09
Study Status, Contacts/Locations v21
Study sites365→369
2021-05-25
Study Status v20
Primary completion date2021-07→2024-10
2021-04-16
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v19
Study sites355→365
InterventionsAbemaciclib (Drug), Entrectinib (Drug), PI3K Inhibitor GDC-0084 (Drug)→Abemaciclib (Drug), Entrectinib (Drug), PI3K Inhibitor paxalisib (Drug)
Eligibility criteria+804 characters
[...] LL PATIENTS) Participants must have histologically confirmed parenchymal metastatic disease to the brain from any solid tumor. Note: [...] ereotactic 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 asymptomati [...] e 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 r [...] y stable from their CNS metastases. Measu [...]
Study description+1 characters
[...] RM II (PI3K GENE MUTATION): Patients receive PI3K inhibitor GDC-0084paxalisib PO once daily (QD) on days 1-28. Cycles repeat every 28 day [...]
2021-03-05
Study Status, Contacts/Locations v18
Study sites354→355
2021-02-05
Study Status, Contacts/Locations v17
Study sites351→354
2021-01-08
Study Status, Contacts/Locations v16
Study sites349→351
2020-12-08
Study Status, Contacts/Locations v15
Study sites347→349
2020-11-10
Study Status, Contacts/Locations v14
Study sites348→347
2020-10-08
Study Status v13
Re-verified, no change to tracked fields
2020-09-29
Study Status, Contacts/Locations v12
Study sites342→348
2020-07-22
Study Status, Contacts/Locations v11
Study sites330→342
2020-06-03
Study Status, Contacts/Locations v10
Study sites309→330
2020-05-06
Study Status, Contacts/Locations v9
Study sites306→309
2020-04-09
Study Status, Contacts/Locations v8
Study sites304→306
2020-03-04
Study Status, Contacts/Locations v7
Study sites297→304
2020-02-04
Study Status, Contacts/Locations v6
Study sites283→297
2020-01-07
Study Status, Contacts/Locations v5
Study sites254→283
2019-11-19
Study Status, Contacts/Locations v4
Study sites200→254
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.
Trial Details
NCT Number NCT03994796
Lead Sponsor Alliance for Clinical Trials in Oncology
Collaborators: National Cancer Institute (NCI), Mirati Therapeutics Inc., Genentech, Inc., Eli Lilly and Company, Kazia Therapeutics Limited
Conditions CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain, Metastatic Malignant Solid Neoplasm, NTRK Family Gene Mutation, PI3K Gene Mutation, ROS1 Gene Mutation, KRAS G12C Mutation
Enrollment 50 participants
Start Date 2019-10-17
Primary Completion 2025-11-13 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-09-28