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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 is a Phase 2 study that was terminated before completion, run by Verastem. The registered enrollment target is 344 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01870609
The ClinicalTrials.gov registry entry for NCT01870609 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 344 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Verastem, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01870609 reports 0 study locations.
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.
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