Genetic Testing in Guiding Treatment for Patients With Brain Metastases

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Abemaciclib — DRUG
  Given PO
• PI3K Inhibitor paxalisib — DRUG
  Given PO
• Entrectinib — DRUG
  Given PO
• Adagrasib — DRUG
  Given PO

Study Details

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.

Key Dates

Start date

Oct 17, 2019

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Jun 30, 2028

Study Design

Enrollment

50 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (CDK gene mutation)
  Patients receive abemaciclib PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm II (PI3K gene mutation)
  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.
• Experimental: Arm III (NTRK/ROS1 gene mutation)
  Patients receive entrectinib PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm IV (KRAS G12C mutation)
  Patients receive adagrasib (MRTX849) PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Objective response rate in the brain [ Time Frame: Up to 5 years ]

Locations (435)

Find similar trials in Anchorage, AK

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