drugset / Trial / NCT02659020
A Study of Olaratumab (LY3012207) in Participants With Advanced Soft Tissue Sarcoma
RandomizedParallel-groupDouble-blindTreatment
Summary
The main purpose of this study is to evaluate the safety and efficacy of two anti-cancer drugs (gemcitabine and docetaxel) with and without the study drug known as olaratumab in participants with advanced soft tissue sarcoma (STS) or STS that has spread to another part(s) of the body.
Timeline
- Start
- 2016-03-01
- Primary completion
- 2020-07-28
- Completion
- 2021-04-27
Outcome
Missed primary endpoint
registry analysis (superiority test); Phase 2: Olaratumab + Gemcitabine + Docetaxel (Olaratumab-naive) vs Phase 2: Placebo + Gemcitabine + Docetaxel (Olaratumab-naive); p = 0.775 NCT02659020 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 900 mg/m2 | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | Olaratumab | Monoclonal antibody | 20 mg/kg | Intravenous |