Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors
Public ClinicalTrials.gov record NCT03709680. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
PHASE 1/2 STUDY TO EVALUATE PALBOCICLIB (IBRANCE®) IN COMBINATION WITH IRINOTECAN AND TEMOZOLOMIDE OR IN COMBINATION WITH TOPOTECAN AND CYCLOPHOSPHAMIDE IN PEDIATRIC PATIENTS WITH RECURRENT OR REFRACTORY SOLID TUMORS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03709680
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 128 participants
Conditions and interventions
Conditions
Interventions
- Palbociclib Drug
- Temozolomide Drug
- Irinotecan Drug
- Topotecan Drug
- Cyclophosphamide Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 20 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 24, 2019 (Actual)
- Primary completion
- Aug 26, 2024 (Actual)
- Completion
- Aug 6, 2025 (Actual)
- Last update posted
- Oct 7, 2026
2019 – 2025
United States locations
- U.S. sites
- 56
- U.S. states
- 24
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham/Children's of Alabama | Birmingham | Alabama | 35233 | — |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | — |
| Children's Hospital Los Angeles Pharmacy Department | Los Angeles | California | 90027 | — |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Children's Hospital and Research Center at Oakland | Oakland | California | 94609 | — |
| Children's Hospital of Orange County | Orange | California | 92868 | — |
| UCSF Benioff Children's Hospital Investigational Pharmacy | San Francisco | California | 94158 | — |
| UCSF Medical Center | San Francisco | California | 94158 | — |
| University of California San Francisco, | San Francisco | California | 94158 | — |
| Children's Hospital Colorado | Aurora | Colorado | 80045 | — |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | — |
| UF Health Shands Hospital | Gainesville | Florida | 32610 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Johns Hopkins All Children's Hospital | St. Petersburg | Florida | 33701 | — |
| Johns Hopkins All Children's Outpatient Care Center | St. Petersburg | Florida | 33701 | — |
| Johns Hopkins All Children's Hospital | Tampa | Florida | 33612 | — |
| Children's Healthcare of Atlanta at Arthur M. Blank Hospital | Atlanta | Georgia | 30329 | — |
| Children's Healthcare of Atlanta at Scottish Rite | Atlanta | Georgia | 30342 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| Johns Hopkins University | Baltimore | Maryland | 21287 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| University of Minnesota Medical Center, Fairview | Minneapolis | Minnesota | 55455 | — |
| University of Minnesota/Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Robert Wood Johnson University Hospital | New Brunswick | New Jersey | 08901 | — |
| CINJ Research Pharmacy | New Brunswick | New Jersey | 08903 | — |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | — |
| Cohen Children's Medical Center | New Hyde Park | New York | 11040 | — |
| Morgan Stanley Children's Hospital of New York-Presbyetrian Hospital | New York | New York | 10032 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | — |
| Cincinnati Children's Liberty Campus | Liberty Township | Ohio | 45044 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| OHSU- Research Pharmacy Services | Portland | Oregon | 97239 | — |
| Oregon Health & Science University | Portland | Oregon | 97239 | — |
| Penn State Children's Hospital and Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Buerger Center for Advanced Pediatric Care | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Medical Center Dallas | Dallas | Texas | 75235 | — |
| Cook Children's Medical Center | Fort Worth | Texas | 76104 | — |
| Cook Children's H/O Infusion Center | Grapevine | Texas | 76051 | — |
| Texas Children's Hospital | Houston | Texas | 77030 | — |
| Children's Medical Center Plano | Plano | Texas | 75024 | — |
| Intermountain - Primary Children's Hospital | Salt Lake City | Utah | 84113 | — |
| Primary Children's Hospital Outpatient Services | Salt Lake City | Utah | 84113 | — |
| Children's Hospital of The King's Daughters | Norfolk | Virginia | 23507 | — |
| Children's Hospital of Richmond at VCU | Richmond | Virginia | 23298 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| Seattle Children's Investigational Drug Service, Pharmacy Department | Seattle | Washington | 98105 | — |
| Children's Wisconsin | Milwaukee | Wisconsin | 53226 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03709680, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 7, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03709680 live on ClinicalTrials.gov.