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Cyclin-Dependent Kinase Inhibitor

Targeted Therapy for Brain Cancer

Phase 2

Recruiting

Research Sponsored by Alliance for Clinical Trials in Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No chemotherapy within 14 days prior to registration

Chronic concomitant treatment with strong CYP3A4 inducers is not allowed

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at whether genetic testing can help guide treatment for brain cancer. Medications that target specific genes may stop the growth of tumor cells.

Who is the study for?

This trial is for patients with solid tumors that have spread to the brain, who can undergo MRI scans and haven't had recent surgery or chemotherapy. They must not be pregnant or nursing, have no uncontrolled medical issues, and not be on certain drugs affecting liver enzymes. Participants need confirmed metastatic disease in the brain from a solid tumor with specific gene alterations (NTRK, ROS1, KRAS G12C, CDK pathway or PI3K pathway) and meet other health criteria.

What is being tested?

The trial tests if genetic testing can guide treatment using targeted medications like abemaciclib, paxalisib, entrectinib and adagrasib for brain metastases from solid tumors. These drugs aim to block enzymes needed by tumor cells to grow by focusing on mutations found in genes related to cancer progression.

What are the potential side effects?

Potential side effects of these treatments may include fatigue; gastrointestinal symptoms like nausea and diarrhea; blood count changes; possible liver enzyme alterations; risk of infections due to immune system impact; as well as unique side effects related to each drug's mechanism of action.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I haven't had chemotherapy in the last 14 days.

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I am not on any strong medication that affects liver enzyme levels.

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My cancer has spread to my brain from another part of my body.

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My cancer has spread to my brain recently or is getting worse.

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I am not currently receiving any cancer treatments.

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I am not on any strong CYP3A4 inhibitors.

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I have tissue samples available from previous surgeries or biopsies for testing.

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My cancer has a specific change in NTRK, ROS1, KRAS G12C, CDK, or PI3K that can be treated.

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I am able to care for myself and perform daily activities.

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My organs are working well and my lab tests are within normal ranges.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes multiply unusually.

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I have a history of cancer.

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I don't have recent heart issues, uncontrolled diabetes, or high protein in my urine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate in the brain

Secondary study objectives

Clinical benefit rate for central nervous system (CNS)

Clinical benefit rate for extracranial disease

Duration of response for brain metastases

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Arm IV (KRAS G12C mutation)Experimental Treatment1 Intervention

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

Group II: Arm III (NTRK/ROS1 gene mutation)Experimental Treatment1 Intervention

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

Group III: Arm II (PI3K gene mutation)Experimental Treatment1 Intervention

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.

Group IV: Arm I (CDK gene mutation)Experimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abemaciclib

2019

Completed Phase 2

~1890

Adagrasib

2023