drugset / Trial / NCT01762033

A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma

NCT01762033

Phase 2 Terminated 40 enrolled Lpath, Inc.
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

EvaluationDrugModalityDoseRoute
Subject sonepcizumab Monoclonal antibody 15 mg/kg Intravenous
Subject sonepcizumab Monoclonal antibody 24 mg/kg Intravenous

Indications