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CDK4/6 Inhibitor

Abemaciclib + Temozolomide - Arm A for Brain Tumor

Phase 2
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to date of death due to any cause (up to approximately 18 months)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event Free Survival as Determined by Blinded Independent Review Committee
Secondary outcome measures
Abemaciclib Acceptability and Palatability Questionnaire
Disease Control Rate (DCR)
Duration of Response (DoR)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Abemaciclib + Temozolomide - Arm AExperimental Treatment2 Interventions
Participants will receive abemaciclib administered orally in addition to temozolomide administered orally or intravenously (IV).
Group II: Temozolomide - Arm BActive Control1 Intervention
Participants will receive temozolomide administered orally or IV.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1930
Abemaciclib
2019
Completed Phase 2
~1710

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,624 Previous Clinical Trials
3,216,879 Total Patients Enrolled
Contact Lilly at 1-800-LillyRx (1-800-545-5979)Study DirectorEli Lilly and Company
6 Previous Clinical Trials
50 Total Patients Enrolled
~30 spots leftby Jul 2027
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