Trials / Active Not Recruiting
Active Not RecruitingNCT06413706
A Study Comparing Abemaciclib Plus Temozolomide to Temozolomide Monotherapy in Children and Young Adults With High-grade Glioma Following Radiotherapy
A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination With Temozolomide Compared to Temozolomide Monotherapy in Children and Young Adults With Newly Diagnosed High-Grade Glioma Following Radiotherapy
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 45 (estimated)
- Sponsor
- Eli Lilly and Company · Industry
- Sex
- All
- Age
- 0 Years – 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to measure the benefit of adding abemaciclib to the chemotherapy, temozolomide, for newly diagnosed high-grade glioma following radiotherapy. Your participation could last approximately 11 months and possibly longer depending upon how you and your tumor respond.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Abemaciclib | Administered orally |
| DRUG | Temozolomide | Administered orally or IV |
Timeline
- Start date
- 2024-10-25
- Primary completion
- 2027-11-01
- Completion
- 2028-02-01
- First posted
- 2024-05-14
- Last updated
- 2026-03-24
Locations
36 sites across 10 countries: United States, Australia, Belgium, Denmark, France, Italy, Japan, Netherlands, Romania, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06413706. Inclusion in this directory is not an endorsement.