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CDK4/6 Inhibitor

Abemaciclib + Temozolomide for Brain Tumors

Phase 2

Recruiting

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

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

Must have

Able to swallow and/or have a gastric/nasogastric tube

Biopsy proven high-grade glioma (HGG) as defined by 2016 World Health Organization (WHO) Classification Criteria, Grade 3-4 including specific subtypes

Must not have

Known pathogenic somatic mutations appropriate for specific inhibitors

Prior malignancy within the previous 3 years affecting study interpretation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to date of death due to any cause (up to approximately 18 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if adding abemaciclib to the chemotherapy drug temozolomide is helpful for treating a specific type of brain tumor. If you join the trial, your participation could

Who is the study for?

This trial is for young individuals with a high-grade glioma, a type of brain tumor, who have completed radiotherapy. The study aims to see if adding abemaciclib to standard chemotherapy (temozolomide) after radiation can be beneficial.

What is being tested?

The study compares the effectiveness of two treatments: one group receives temozolomide alone, while the other group gets both temozolomide and abemaciclib. Participants will be monitored for about 11 months or more depending on their response.

What are the potential side effects?

Possible side effects include those commonly associated with chemotherapy such as nausea, fatigue, hair loss, and increased risk of infection. Abemaciclib may also cause diarrhea and low white blood cell counts.

Eligibility Criteria

Inclusion Criteria

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

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I can swallow or have a tube for feeding.

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My biopsy shows I have a high-grade brain tumor (Grade 3-4).

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My doctor expects me to live for at least 8 more weeks.

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My health score is 60 or above on a specific scale.

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My condition meets the 2021 WHO criteria for specific genetic changes.

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It has been over 28 days since my last major surgery or serious injury.

Exclusion Criteria

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

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My cancer has a mutation that can be targeted by specific drugs.

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I have not had any other cancers in the past 3 years that could affect this study.

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I have had surgery or radiotherapy for my high-grade glioma.

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My cancer is a specific type of brain tumor located in the pons.

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My high-grade glioma has come back or didn't respond to treatment, including after radiotherapy.

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My high-grade glioma developed from a previously treated lower-grade brain tumor.

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I am currently receiving IV therapy for a serious infection.

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I have not received a live virus vaccine in the last 28 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to date of death due to any cause (up to approximately 18 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to date of death due to any cause (up to approximately 18 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to date of death due to any cause (up to approximately 18 months) for reporting.