Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Solid Tumors and Neuroblastoma, sponsored by Pfizer.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
EFS is defined as the time from randomization until first event (ie, progression, recurrence following response, second malignancy or death without progression or recurrence).
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 |
What the registry record for NCT03709680 still lists
NCT03709680 is an interventional study that assigns participants to a tested intervention. The registered 128 participants enrollment target is mid-sized for trials with a published cap, below the 284-participant average among 125 other Solid Tumors trials with a reported enrollment target (55% lower).
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 names 20 study sites across 8 states, led by 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.
Learn More About Clinical Trials
Similar trials for Solid Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03709680's enrollment target sits among peer trials
128 46th of 125 higher than 80 of 125 other Solid Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
RECRUITING · Phase 2
-
Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study
RECRUITING · Phase 2
-
APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors
RECRUITING · Phase 2
-
A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy
RECRUITING · Phase 2
-
Phase II Biomarker Study of SAR444881 in Combination With Cemiplimab in Solid Tumors
RECRUITING · Phase 2
-
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02870738 · 128 participants · Phase 2
Bladder Directed vs. Pelvic Floor Therapy in IC/BPS
- NCT03294460 · 128 participants · Phase 1
Nicotinic Receptor Genetic Variation and Alcohol Reward
- NCT04149977 · 128 participants · NA
Blood Flow Restriction Therapy in Lower Limb Extensor Injuries
- NCT04373057 · 128 participants · Phase 1
Prebiotic Galacto-oligosaccharide and Acute GVHD
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI