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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).

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

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival

Secondary outcome measures

Objective radiographic response (ORR)

Overall Survival

Progression Free Survival

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

Abemaciclib 200mg tablet PO twice daily administered on 28-day cycles Subjects remain on treatment until tumor progression or unacceptable toxicity.

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

Abramson Cancer Center at Penn MedicineOTHER

387 Previous Clinical Trials

145,685 Total Patients Enrolled

1 Trials studying Oligodendroglioma

23 Patients Enrolled for Oligodendroglioma

Stephen Bagley, MD, MSCELead Sponsor

1 Previous Clinical Trials

55 Total Patients Enrolled

1 Trials studying Oligodendroglioma

55 Patients Enrolled for Oligodendroglioma

University of PennsylvaniaOTHER

2,000 Previous Clinical Trials

42,880,078 Total Patients Enrolled

1 Trials studying Oligodendroglioma

55 Patients Enrolled for Oligodendroglioma

Media Library

Abemaciclib (CDK4/6 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03969706 — Phase 2

Oligodendroglioma Research Study Groups: Single Arm

Oligodendroglioma Clinical Trial 2023: Abemaciclib Highlights & Side Effects. Trial Name: NCT03969706 — Phase 2

Abemaciclib (CDK4/6 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03969706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the required qualifications able to join this trial at this time?

"Unfortunately, this study is not presently looking for new patients. The clinical trial was initially posted on May 15th, 2019 and was most recently edited on September 6th, 2022. However, there are 33 other trials actively enrolling patients with oligodendroglioma and 96 trials for Abemaciclib 200 MG that are still recruiting participants."

Answered by AI

What are some of the illnesses that Abemaciclib 200 MG has been shown to improve?

"Abemaciclib 200 MG is most often used to treat patients with a high risk of recurrence. However, this medication can also be effective for managing advanced HR+HER2- breast cancer, endocrine therapy, and breast."

Answered by AI