drugset / Trial / NCT01762033
A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma
NaSingle-groupOpen-labelTreatment
Summary
This Phase 2a study will investigate the efficacy, safety and tolerability of ASONEP™ (sonepcizumab/LT1009) when administered intravenously once a week, every 4 weeks (or cycle), to subjects with refractory renal cell carcinoma (RCC) until the disease progresses. Subjects who have failed 3 prior treatments for RCC including vascular endothelial growth factor (VEGF) and/or mammalian target of rapamycin (mTOR) inhibitors or who have tumors that cannot be surgically removed will be eligible for screening.
Timeline
- Start
- 2013-02
- Primary completion
- 2015-09
- Completion
- 2015-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | sonepcizumab | Monoclonal antibody | 15 mg/kg | Intravenous |
| Subject | sonepcizumab | Monoclonal antibody | 24 mg/kg | Intravenous |