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NCT01870609 · ClinicalTrials.gov registry record · Phase 2
Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma
A Phase 2 study, sponsored by Verastem.
- Terminated
- Registry status
- Phase 2
- Development phase
- 344
- Enrollment target
NCT01870609: Clinical Trial Phase 2 study, sponsored by Verastem.
NCT01870609 is a Phase 2 study that was terminated before completion, run by Verastem. The registered enrollment target is 344 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01870609, a Phase 2 study, was terminated before completion, sponsored by Verastem.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 344 participants
- Enrollment target
Study Summary
This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin. Prior to entry and randomization to the study, each subject must have tumor Merlin status(high or low) established by immunohistochemistry performed at a central laboratory. Subjects will be randomized in a 1:1 ratio to receive oral VS-6063 400 mg twice per day, or matched placebo. Randomization will be stratified by tumor Merlin status (high versus low). Progression will be assessed both locally and by central review using the Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1. Subjects will continue to receive treatment until disease progression or other discontinuation criteria are met. Following documentation of nonfatal disease progression, all subjects will be followed for overall survival by telephone contact every 2 months until end of life or the close of the study.
Primary Outcome
The median duration of OS will be estimated based on the 50th percentile of the Kaplan-Meier distribution
Interventions
- DRUG Placebo
- DRUG defactinib (VS-6063)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 344 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
Why NCT01870609 stopped before completion
NCT01870609 is an interventional study that assigns participants to a tested intervention. The registered 344 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (159% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01870609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01870609 about?
NCT01870609 is a clinical study titled "Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma". This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or...
What is the current status of trial NCT01870609?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 344 participants. The study started on 2013-09. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01870609?
The interventions under investigation include: Placebo (DRUG), defactinib (VS-6063) (DRUG).
Who is sponsoring clinical trial NCT01870609?
This trial is sponsored by Verastem, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01870609's enrollment target sits among peer trials
344 136th of 2000 higher than 1,865 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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