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NCT03709680 · ClinicalTrials.gov registry record · Phase 2
Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
A Phase 2 study of Solid Tumors and Neuroblastoma, sponsored by Pfizer.
- Active
- Registry status
- Phase 2
- Development phase
- 128
- Enrollment target
- 20
- Study locations
NCT03709680 is a Phase 2 study of Solid Tumors and Neuroblastoma that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 128 participants, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (55% lower). The trial reports 20 study locations across 8 states.
The verdict
NCT03709680, a Phase 2 study of Solid Tumors and Neuroblastoma, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 128 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Temozolomide
- DRUG Palbociclib
- DRUG Irinotecan
- DRUG Topotecan
Study Locations (20)
California
- MemorialCare Health System - Long Beach Medical Center - Long Beach
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital and Research Center at Oakland - Oakland
- Children's Hospital of Orange County - Orange
- Lucile Packard Children's Hospital - Palo Alto
- UCSF Medical Center - San Francisco
- University of California San Francisco, - San Francisco
Florida
- UF Health Shands Hospital - Gainesville
- University of Florida College of Medicine - Gainesville
- Johns Hopkins All Children's Hospital - St. Petersburg
- Johns Hopkins All Children's Outpatient Care Center - St. Petersburg
- Johns Hopkins All Children's Hospital - Tampa
Georgia
- Children's Healthcare of Atlanta at Egleston - Atlanta
- Children's Healthcare of Atlanta at Scottish Rite - Atlanta
- Children's Healthcare of Atlanta, Medical Office Building - Atlanta
Alabama
- University of Alabama at Birmingham/Children's of Alabama - Birmingham
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Hospital - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2019-05-24 |
| Est. Completion | 2025-10-18 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03709680
The ClinicalTrials.gov registry entry for NCT03709680 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (55% lower). The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 7 conditions, with Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03709680 reports 20 study locations spanning 8 distinct geographic areas - top geographies include California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT03709680 about?
NCT03709680 is a clinical study titled "Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors". 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...
What is the current status of trial NCT03709680?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 128 participants. The study started on 2019-05-24. Estimated completion is 2025-10-18.
What conditions does trial NCT03709680 study?
This clinical trial studies the following conditions: Solid Tumors, Neuroblastoma, Rhabdomyosarcoma, Medulloblastoma, Diffuse Intrinsic Pontine Glioma.
What interventions are being tested in trial NCT03709680?
The interventions under investigation include: Cyclophosphamide (DRUG), Temozolomide (DRUG), Palbociclib (DRUG), Irinotecan (DRUG), Topotecan (DRUG).
Who is sponsoring clinical trial NCT03709680?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03709680 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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