drugset / Trial / NCT05440786
CAMPFIRE: A Study of Abemaciclib (LY2835219) in Participants With Ewing's Sarcoma
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolomide) for Ewing's sarcoma that has come back or did not respond to treatment. This trial is part of the CAMPFIRE master protocol, which is a platform to speed development of new treatments for children and young adults with cancer. Your participation in this trial could last 11 months or longer, depending on how you and your tumor respond.
Timeline
- Start
- 2022-09-20
- Primary completion
- 2025-01-15
- Completion
- 2026-12
Outcome
Mixed primary results
registry Posterior Mean Hazard Ratio 0.530 (80% CI 0.317 to 0.783) NCT05440786 ↗
registry p = 0.281; Hazard Ratio (HR) 0.639 (95% CI 0.282 to 1.449) NCT05440786 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abemaciclib | Small molecule | 55 mg/m2 | Oral |
| Subject | Abemaciclib | Small molecule | 100 mg | Oral |
| Background | Irinotecan | Small molecule | 50 mg/m2 | Intravenous |
| Background | Temozolomide | Small molecule | 100 mg/m2 | Oral |