Genetic Testing in Guiding Treatment for Patients With Brain Metastases (NCT03994796) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
United States50 participantsStarted 2019-10-17
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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. 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…