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CLINICAL TRIALS
About Clinical Trials Find a Clinical Trial
CLINICAL TRIALS
About Clinical Trials Find a Clinical Trial

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

Trial ID or NCT#

NCT03709680

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE(REGISTERED)) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE AND/OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS

Eligibility Criteria

Ages Eligible for Study: 2 Years to 20 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Jay Michael S. Balagtas

Contact us to find out if this trial is right for you.

CONTACT

Richard Fu
(650) 721-4074

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View on ClinicalTrials.gov