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NCT01762033 · ClinicalTrials.gov registry record · Phase 2
A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma
A Phase 2 study, sponsored by Lpath.
- Terminated
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT01762033: Clinical Trial Phase 2 study, sponsored by Lpath.
NCT01762033 is a Phase 2 study that was terminated before completion, run by Lpath. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01762033, a Phase 2 study, was terminated before completion, sponsored by Lpath.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
The study will use a two-cohort design based on an 8-week PFS rate. Treatment will be considered promising if at least 12 out of the first 22 eligible subjects entered in the Cohort 1 of the study are progression free at Week 8. Enrollment of Cohort 2 will then proceed and be considered worthy of further evaluation if at least 25 out of 39 eligible subjects are progression free at Week 8. If no efficacy signal is observed after enrollment of 22 subjects in Cohort 1, the second cohort will not be
Interventions
- DRUG ASONEP
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2013-02 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
Why NCT01762033 stopped before completion
NCT01762033 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 1 intervention - of which ASONEP is the first listed.
NCT01762033 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01762033 about?
NCT01762033 is a clinical study titled "A Phase 2 Study of ASONEP™ to Treat Unresectable and Refractory Renal Cell Carcinoma". 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 tre...
What is the current status of trial NCT01762033?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2013-02. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01762033?
The interventions under investigation include: ASONEP (DRUG).
Who is sponsoring clinical trial NCT01762033?
This trial is sponsored by Lpath, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01762033's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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