drugset / Trial / NCT01574716
Sarcoma Study of MORAb-004 Utilization: Research and Clinical Evaluation
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being done to see if MORAb-004 increases the effectiveness of the chemotherapies gemcitabine and docetaxel in people with metastatic Soft Tissue Sarcoma.
Timeline
- Start
- 2012-08-07
- Primary completion
- 2015-08-11
- Completion
- 2016-08-02
Outcome
Missed primary endpoint
registry p = 0.6562; Hazard Ratio (HR) 1.08 (95% CI 0.77 to 1.50); Log Rank NCT01574716 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ontuxizumab | Monoclonal antibody | 4 mg/kg | Intravenous |
| Subject | Ontuxizumab | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Ontuxizumab | Monoclonal antibody | 8 mg/kg | Intravenous |
| Comparator | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 900 mg/m2 | Intravenous |