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

  • STATUS
    Recruiting
  • End date
    Sep 26, 2024
  • participants needed
    167
  • sponsor
    Pfizer
Updated on 3 December 2021
platelet count
renal function
cyclophosphamide
lymphoma
measurable disease
bone marrow procedure
biological factors
neutrophil count
irinotecan
blood transfusion
cancer chemotherapy
temozolomide
biological therapy
solid tumour
solid tumor
alopecia
palbociclib
sarcoma
ewing's sarcoma
dipg
medulloblastoma
renal function test
diffuse intrinsic pontine glioma
topotecan
central nervous system tumor
kidney function test
rhabdoid tumor

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.

Details
Condition Solid Tumour, Rhabdoid Tumor, Rhabdomyosarcoma, neuroblastomas, Ewing's sarcoma, Gliomas, DIPG, Solid Neoplasm, Solid Tumors, Medulloblastoma, Diffuse Intrinsic Pontine Glioma, Glioma, Neuroblastoma
Treatment cyclophosphamide, Topotecan, Temozolomide, Irinotecan, Palbociclib
Clinical Study IdentifierNCT03709680
SponsorPfizer
Last Modified on3 December 2021

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