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Genetic Testing in Guiding Treatment for Patients With Brain Metastases

NCT03994796 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

  • Metastatic Malignant Neoplasm in the Brain
  • Metastatic Malignant Solid Neoplasm
  • NTRK Family Gene Mutation
  • PI3K Gene Mutation
  • ROS1 Gene Mutation
  • KRAS G12C Mutation
  • CDK Gene Mutation

Interventions

DRUG

Abemaciclib

Given PO

DRUG

PI3K Inhibitor paxalisib

Given PO

DRUG

Entrectinib

Given PO

DRUG

Adagrasib

Given PO

Sponsors & Collaborators

Principal Investigators

  • Priscilla Brastianos, MD · Massachusetts General Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-17
Primary Completion
2026-10-31
Completion
2028-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03994796 on ClinicalTrials.gov