13Y-MC-JPCS (Abemaciclib)
A Phase 1b Dose Escalation Study of Abemaciclib in Combination with Temozolomide and Irinotecan (Part A) and Abemaciclib in Combination with Temozolomide (Part B) in Pediatric and Young Adult Patients with Relapsed/Refractory Solid Tumors
Recruiting
Summary
The clinical study I3Y-MC-JPCS is designed to assess the pharmacokinetics, safety, and tolerability to determine the recommended Phase 2 dose for abemaciclib in combination with temozolomide and irinotecan (Part A) and abemaciclib in combination with temozolomide (Part B) in pediatric and young adult patients with relapsed/refractory solid tumors (≤ 18 years).
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.
Abemaciclib is taken orally over 28-days cycles as tablets twice a day. On days 1 to 5 of each treatment cycle, patients in arm A also receive irinotecan as an infusion together with orally administered temozolomide.
Main inclusion criteria
- Pediatric and adolescents patients ≤18 years with any relapsed/refractory malignant solid tumors (excluding lymphoma), including CNS tumors, that have progressed on standard therapies
- Body weight ≥10 kg and BSA ≥0.5 m²
- Karnofsky oder Lansky > 50
- Patients must be able to swallow
Sponsor
Eli Lilly