Trials / Terminated
TerminatedNCT01991938
Phase I Dose Escalation Study of VS-5584 in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
A Phase I Dose Escalation Study of VS-5584, a Dual PI3K/mTOR Inhibitor, in Subjects With Advanced Non-Hematologic Malignancies or Lymphoma
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 75 (actual)
- Sponsor
- Verastem, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VS-5584 |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-12-01
- Completion
- 2016-12-01
- First posted
- 2013-11-25
- Last updated
- 2017-01-27
Locations
5 sites across 2 countries: United States, United Kingdom
Source: ClinicalTrials.gov record NCT01991938. Inclusion in this directory is not an endorsement.