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NCT01991938 · ClinicalTrials.gov registry record · Phase 1
Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
A Phase 1 study, sponsored by Verastem.
- Terminated
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01991938: Clinical Trial Phase 1 study, sponsored by Verastem.
NCT01991938 is a Phase 1 study that was terminated before completion, run by Verastem. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01991938, a Phase 1 study, was terminated before completion, sponsored by Verastem.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this study is to evaluate the safety (including the recommended Phase II dose), pharmacokinetics (the amount of VS-5584 in subject's blood) and the anti-cancer activity of VS-5584. Biomarkers (genes or proteins that may predict or show how subject's body may respond to VS-5584) will also be assessed in archival tumor tissue, tumor biopsies (in consenting subjects), and blood samples.
Primary Outcome
Serious Adverse events, Adverse events and their frequency, duration and severity, physical examination, laboratory parameters, vital signs and ECGs as determined based on CTCAE (Common Toxicity Criteria for Adverse Effects) V4.03. A Safety Monitoring Committee will review safety information.
Interventions
- DRUG VS-5584
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
Why NCT01991938 stopped before completion
NCT01991938 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 1 intervention - of which VS-5584 is the first listed.
NCT01991938 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01991938 about?
NCT01991938 is a clinical study titled "Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma". This is a Phase I, open-label, multicenter, dose-escalation trial of VS-5584, a PI3K/mTOR kinase inhibitor, in subjects with advanced non-hematologic malignancies or lymphoma. This clinical study is comprised of 2 sequential parts: Part 1 (Dose Escalation) and Part 2 (Expansion). The purpose of this...
What is the current status of trial NCT01991938?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2013-11. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01991938?
The interventions under investigation include: VS-5584 (DRUG).
Who is sponsoring clinical trial NCT01991938?
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 NCT01991938's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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