A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma
NCT01762033 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2016-01-20
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.
Conditions
Interventions
- DRUG
-
ASONEP
Intravenous infusion
Sponsors & Collaborators
-
Lpath, Inc.
lead INDUSTRY
Principal Investigators
-
Susan Hazel · Lpath, Inc.
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2015-09-30
- Completion
- 2015-09-30
Countries
- United States
Study Locations
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