Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
Status:
Recruiting
Trial end date:
2024-09-26
Target enrollment:
Participant gender:
Summary
This study will evaluate palbociclib in combination with chemotherapy (temozolomide with
irinotecan and/or topotecan with cyclophosphamide) in children, adolescents and young adults
with recurrent or refractory solid tumors. The main purpose of phase 1 portion of this study
is to evaluate the safety of palbociclib in combination with chemotherapy in order to
estimate the maximum tolerated dose. The main purpose of phase 2 portion is to compare the
efficacy of palbociclib in combination with irinotecan and temozolomide vs irinotecan and
temozolomide alone in the treatment of children, adolescents, and young adults with recurrent
or refractory Ewing sarcoma (EWS). Pharmacokinetics and efficacy of palbociclib in
combination with chemotherapy will be evaluated.