drugset / Trial / NCT02677116
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
Non-randomizedSingle-groupOpen-labelTreatment
Summary
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies. The present study is open to children with advanced cancer or cancer that has spread to another part of the body. The study has three parts. In the first two parts, a specific dose of olaratumab will be given in 21 day cycles, followed by one of three standard chemotherapy regimens. In the third part, a specific dose of olaratumab will be given with one of three standard chemotherapy regimens in 21 day cycles. Participants will only enroll in one part.
Timeline
- Start
- 2016-08-29
- Primary completion
- 2018-10-10
- Completion
- 2019-04-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Doxorubicin | Other / unclassified | — | Intravenous |
| Subject | Ifosfamide | Small molecule | — | Intravenous |
| Subject | Irinotecan | Small molecule | — | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 20 mg/kg | Intravenous |
| Subject | Vincristine | Small molecule | — | Intravenous |