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PHASE 1 STUDY TO EVALUATE THE SAFETY AND PHARMACOKINETICS OF PALBOCICLIB (IBRANCE (REGISTERED)) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Status
Active
Cancer Type
Ewing Sarcoma
Neuroblastoma
Trial Phase
Phase I
Eligibility
2 - 20 Years, Male and Female
Study Type
Treatment
NCD ID
NCT03709680
Protocol IDs
A5481092 (primary)
NCI-2019-02215
Study Sponsor
Pfizer

Summary

This study will evaluate palbociclib in combination with chemotherapy (temozolomide and irinotecan) in children, adolescents and young adults with recurrent or refractory solid tumors. The main purpose of this study is to evaluate the safety of palbociclib in combination with chemotherapy in order to estimate the maximum tolerated dose. Pharmacokinetics and efficacy of palbociclib in combination with chemotherapy will be evaluated.
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