J1S-MC-JP04 CAMPFIRE (Abemaciclib)
A Randomized, Open-Label, Phase 2 Study Evaluating Abemaciclib in Combination with Irinotecan and Temozolomide in Participants with Relapsed or Refractory Ewing’s Sarcoma
Rekrutierung beendet
Summary
The purpose of this study is to measure the benefit of adding abemaciclib to chemotherapy (irinotecan and temozolamide) for Ewing's sarcoma that has come back or did not respond to treatment (R/R). 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.
Abemaciclib is a selective and potent small-molecule cyclin-dependent kinase 4 and cyclin-dependent kinase 6 (CDK4 & 6) inhibitor. Since these kinases are important regulators of the cell cycle in many tumors, inhibition is expected to potentiate the effect of chemotherapy.
Recruitment in this study was completed in July 2024.
Main inclusion criteria
- Age: ≥ 1 to < 39 years
- Diagnosis of Relapsed or Refractory Ewing's Sarcoma or Ewing's sarcoma-like tumor
- Must have one measurable or evaluable lesion
- Body weight ≥10 kilograms (kg)
- Karnofsky oder Lansky ≥ 50
Sponsor
Eli Lilly