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CDK4/6 Inhibitor

Abemaciclib for Brain Cancer

Phase 2

Waitlist Available

Led By Stephen Bagley, MD

Research Sponsored by Stephen Bagley, MD, MSCE

Eligibility Criteria Checklist

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

Must have

Oligodendroglioma must be progressive or recurrent following BOTH a) prior radiation therapy and b) at least one prior line of alkylating chemotherapy.

Adequate hepatic function within 7 days prior to enrollment, defined as follows: Total bilirubin ≤ 1.5 x ULN (patients with Gilbert's Syndrome with a total bilirubin ≤ 2.0 mg/dl and direct bilirubin within normal limits are permitted), ALT and AST ≤ 3x upper limit of normal (ULN).

Must not have

Females who are pregnant or lactating are excluded

Subjects requiring concurrent administration of any other anticancer agents including chemotherapy and biologic agents (such as bevacizumab) or the use of other concurrent investigational treatment drugs and/or devices

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug to see if it can help people with a specific type of brain tumor.

Who is the study for?

Adults with recurrent oligodendroglioma, confirmed by specific molecular markers (1p/19q codeletion), who have had prior radiation and chemotherapy can join. They must be able to take oral meds, have a life expectancy over 3 months, good performance status, and adequate organ function. Pregnant or breastfeeding women are excluded.

What is being tested?

The trial is testing the effectiveness of abemaciclib at a dose of 200 MG in patients with recurrent oligodendroglioma. It's an open-label study where all participants receive the drug to see how well it works against this type of brain tumor.

What are the potential side effects?

While not specified here, common side effects for drugs like abemaciclib may include diarrhea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems, liver issues, and potential harm to unborn babies.

Eligibility Criteria

Inclusion Criteria

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

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My oligodendroglioma has worsened after radiation and chemotherapy.

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My liver tests are within the required range for the study.

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I have waited the required time after my last cancer treatment before joining this trial.

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My tumor is a type of brain cancer called oligodendroglioma with specific genetic features.

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My liver is functioning well, based on recent tests.

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My oligodendroglioma has worsened after radiation and chemotherapy.

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I am 18 years old or older.

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I can care for myself but may need occasional help.

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I can swallow pills.

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My kidney function is within the required range for the study.

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My tumor is confirmed as oligodendroglioma with 1p/19q codeletion.

Exclusion Criteria

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

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I am not pregnant or breastfeeding.

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I am not currently using any other cancer treatments or investigational drugs.

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I do not have severe lung problems, major stomach surgery, Crohn's, ulcerative colitis, or chronic severe diarrhea.

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I have a history of serious heart rhythm problems or sudden cardiac arrest.

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I have been treated with a CDK4/6 inhibitor before.

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I am not taking seizure medications like carbamazepine, phenytoin, or phenobarbital.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years for reporting.