Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies
Public ClinicalTrials.gov record NCT01683149. 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 I, Traditional 3+3, Trial of PO Sorafenib and Topotecan in Refractory or Recurrent Pediatric Solid Malignancies
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
H. Lee Moffitt Cancer Center and Research Institute will be the Sunshine Project Coordinator, but will not be recruiting locally. The purpose of this research study is to establish a dose of the combination of drugs, Topotecan and Sorafenib in children. This will be called the maximum tolerated dose. The chemotherapy in this study is a combination of Topotecan and Sorafenib. The investigators are trying to find the highest dose of Topotecan and Sorafenib that can be given safely to children with Refractory or Recurrent Pediatric Solid Malignancies. The investigators will do this by testing different doses of these drugs in different groups of children. The investigators will also study how the body processes these drugs.
Study identification
- NCT ID
- NCT01683149
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 13 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 3 Years to 18 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
- Jan 2013 (Type not available)
- Primary completion
- Jan 2016 (Actual)
- Completion
- Jan 2016 (Actual)
- Last update posted
- Mar 4, 2016
2013 – 2016
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Childrens Hospital Los Angeles | Los Angeles | California | 90027 | — |
| Connecticut Childrens Medical Center | Hartford | Connecticut | 06106 | — |
| Nemours/Alfred I. duPont Hospital for Children, Delaware | Wilmington | Delaware | 19803 | — |
| University of Florida, Gainesville | Gainesville | Florida | 32610 | — |
| Nemours Children's Clinic, Jacksonville | Jacksonville | Florida | 32207 | — |
| University of Miami, Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| All Children's Hospital, St. Petersburg | St. Petersburg | Florida | 33701 | — |
| Montefiore Medical Center, Children's Hospital at Montefiore | The Bronx | New York | 10467 | — |
| Primary Children's Medical Center/Utah | Salt Lake City | Utah | 84113 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01683149, 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 Mar 4, 2016 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01683149 live on ClinicalTrials.gov.