Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
Running, not enrolling · Phase 2
Conditions studied: Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor, Rhabdomyosarcoma, Neuroblastoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma
In brief
A study to learn about safety and find out maximum tolerable dose of palbociclib given in combination with chemotherapy (temozolomide with irinotecan or topotecan with cyclophosphamide) in children, adolescents and young adults with recurrent or refractory solid tumors (phase 1). Neuroblastoma tumor specific cohort to further evaluate antitumor activity of palbociclib in combination with topotecan and cyclophosphamide in children, adolescents, and young adults with recurrent or refractory neuroblastoma. Phase 2 to learn about the efficacy of palbociclib in combination with irinotecan and temozolomide when compared with irinotecan and temozolomide alone in the treatment of children, adolescents, and young adults with recurrent or refractory Ewing sarcoma (EWS).
Key facts
- Study ID
- NCT03709680
- Run by
- Pfizer
- People needed
- 128
- Starts
- 2019-05-24
- Expected to finish
- 2025-10-18
- Last updated by the study team
- 2025-01-14
Who can join
Age: 2 and older, up to 20. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Phoenix Children's Hospital — Phoenix, Arizona, United States
- MemorialCare Health System - Long Beach Medical Center — Long Beach, California, United States
- Children's Hospital Los Angeles — Los Angeles, California, United States
- Children's Hospital and Research Center at Oakland — Oakland, California, United States
- Children's Hospital of Orange County — Orange, California, United States
- Lucile Packard Children's Hospital — Palo Alto, California, United States
- UCSF Medical Center — San Francisco, California, United States
- University of California San Francisco, — San Francisco, California, United States
- Children's Hospital Colorado — Aurora, Colorado, United States
- Children's National Hospital — Washington D.C., District of Columbia, United States
- UF Health Shands Hospital — Gainesville, Florida, United States
- University of Florida College of Medicine — Gainesville, Florida, United States
- Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
- Johns Hopkins All Children's Outpatient Care Center — St. Petersburg, Florida, United States
- Johns Hopkins All Children's Hospital — Tampa, Florida, United States
- Children's Healthcare of Atlanta at Egleston — Atlanta, Georgia, United States
- Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia, United States
- Children's Healthcare of Atlanta, Medical Office Building — Atlanta, Georgia, United States
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- Indiana University — Indianapolis, Indiana, United States
- Norton Children's Hospital — Louisville, Kentucky, United States
- Novak Center for Children's Health — Louisville, Kentucky, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- University of Michigan Health System — Ann Arbor, Michigan, United States
- University of Alabama at Birmingham/Children's of Alabama — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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