*Study Of Palbociclib Combined With Chemotherapy
Research type
Research Study
Full title
PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE® ) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE INPEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
IRAS ID
1005857
Contact name
Prashanth Gopalakrishna
Contact email
Sponsor organisation
Pfizer Inc.
Eudract number
2021-003444-25
Clinicaltrials.gov Identifier
Research summary
This study will evaluate palbociclib in combination with chemotherapy (temozolomide (TMZ) with irinotecan (IRN) or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumours. The phase 1 portion of the study has been completed. The UK will participate in the phase 2 portion of the study only.
The main purpose of phase 2 portion is to evaluate how well the combination of palbociclib with IRN and TMZ works and how well tolerated it is compared with IRN and TMZ alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS) for whom no standard therapy is available. The study will also look at the amount of study drug in the blood and how it is changed and removed from the body (pharmacokinetics) as well as the impact of the combination of palbociclib with TMZ and IRN treatment on patient quality of life.
Researchers will evaluate if the addition of palbociclib to the chemotherapy combination of IRN and TMZ is safe and possibly more effective in the treatment of recurrent/refractory EWS.REC name
London - Brent Research Ethics Committee
REC reference
22/LO/0648
Date of REC Opinion
1 Mar 2023
REC opinion
Further Information Favourable Opinion