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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate in the brain
Secondary outcome measures
Clinical benefit rate for central nervous system (CNS)
Clinical benefit rate for extracranial disease
Duration of response for brain metastases
+7 more

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
Adagrasib
2023
Completed Phase 1
~20
Abemaciclib
2019
Completed Phase 2
~1710
Entrectinib
2014
Completed Phase 2
~360

Find a Location

Who is running the clinical trial?

Mirati Therapeutics Inc.Industry Sponsor
70 Previous Clinical Trials
7,877 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,624 Previous Clinical Trials
3,216,743 Total Patients Enrolled
Kazia Therapeutics LimitedIndustry Sponsor
11 Previous Clinical Trials
1,404 Total Patients Enrolled

Media Library

Abemaciclib (Cyclin-Dependent Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03994796 — Phase 2
Brain Metastasis Research Study Groups: Arm IV (KRAS G12C mutation), Arm I (CDK gene mutation), Arm III (NTRK/ROS1 gene mutation), Arm II (PI3K gene mutation)
Brain Metastasis Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03994796 — Phase 2
Abemaciclib (Cyclin-Dependent Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03994796 — Phase 2
~9 spots leftby Oct 2024
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