drugset / Trial / NCT01683149
Sorafenib and Topotecan in Refractory/Recurrent Pediatric Malignancies
Phase 1
Completed
13 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Bayer · collabPediatric Cancer Foundation · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2013-01
- Primary completion
- 2016-01
- Completion
- 2016-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sorafenib | Small molecule | 100 mg/m2 | Oral |
| Subject | Sorafenib | Small molecule | 150 mg/m2 | Oral |
| Subject | Sorafenib | Small molecule | 200 mg/m2 | Oral |
| Subject | Topotecan | Small molecule | 0.8 mg/m2 | Oral |
| Subject | Topotecan | Small molecule | 1 mg/m2 | Oral |
| Subject | Topotecan | Small molecule | 1.4 mg/m2 | Oral |
| Subject | Topotecan | Small molecule | 1.8 mg/m2 | Oral |