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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 is a Phase 1 study that was terminated before completion, run by Verastem. The registered enrollment target is 75 participants.
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.
Interventions
- DRUG VS-5584
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2013-11 |
| Est. Completion | 2016-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01991938
The ClinicalTrials.gov registry entry for NCT01991938 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 75 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 1 intervention - of which VS-5584 is the first listed.
NCT01991938 reports 0 study locations.
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.
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