Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-04-15 @ 4:58 PM
Study NCT ID:
NCT01762033
Status:
TERMINATED
Last Update Posted:
2016-01-20
First Post:
2012-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma
Sponsor:
Lpath, Inc.
Organization:
Study Overview
Official Title:
A Multi-Center, Open-Label, Single-Arm, Phase 2 Study of ASONEP™ (Sonepcizumab/LT1009) Administered as a Single Agent to Subjects With Refractory Renal Cell Carcinoma
Status:
TERMINATED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
LT1009-Onc-002 is a Phase 2a open-label, multi-center study designed to evaluate the efficacy and safety of ASONEP (sonepcizumab/LT1009) monotherapy in subjects with advanced, unresectable, refractory RCC who have previously failed up to 3 therapies, including VEGF and/or mTOR inhibitors. Two cohorts will be enrolled for a total of up to 39 subjects. Subjects will receive an intravenous (IV) infusion of ASONEP™ over 90 minutes at 24 mg/kg once a week and progression-free survival (PFS) will be assessed after 8 weeks of treatment. Cohort 1 will enroll approximately 22 subjects. A second cohort of up to 17 subjects will be enrolled if at least 12 out of 22 subjects from Cohort 1 demonstrated PFS at 8 weeks. Weekly dosing will take place from the date of randomization until the date of first documented progression or date of death from any cause, whichever comes first.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: