Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors

  • End date
    Dec 6, 2024
  • participants needed
  • sponsor
Updated on 9 June 2022
platelet count
renal function
measurable disease
bone marrow procedure
biological factors
neutrophil count
blood transfusion
cancer chemotherapy
biological therapy
solid tumour
solid tumor
ewing's sarcoma
renal function test
diffuse intrinsic pontine glioma
central nervous system tumor
kidney function test
rhabdoid tumor


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.

Condition Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
Treatment cyclophosphamide, Topotecan, Temozolomide, Irinotecan, Palbociclib
Clinical Study IdentifierNCT03709680
Last Modified on9 June 2022


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