Trials / Completed
CompletedNCT01778803
Phase I/Ib Study of Paclitaxel in Combination With VS-6063 in Patients With Advanced Ovarian Cancer
A Phase I/Ib Study of Paclitaxel in Combination With VS-6063, a Focal Adhesion Kinase Inhibitor, in Subjects With Advanced Ovarian Cancer
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Verastem, Inc. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase I/Ib, open-label, multicenter, dose-escalation trial of paclitaxel in combination with defactinib (VS-6063), a focal adhesion kinase inhibitor, in patients with advanced ovarian cancer. This clinical study is comprised of 2 parts: Phase I (Dose Escalation) and Phase Ib (Expansion). The purpose of this study is to assess assess the safety (including the recommended phase 2 dose), the pharmacokinetics, and the anti-cancer activity of defactinib (VS-6063) when administered in combination with paclitaxel. Pharmacodynamic effects will also be examined in tumor biopsies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | defactinib | |
| DRUG | Paclitaxel |
Timeline
- Start date
- 2013-02-26
- Primary completion
- 2015-02-23
- Completion
- 2015-02-23
- First posted
- 2013-01-29
- Last updated
- 2017-05-17
Locations
3 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01778803. Inclusion in this directory is not an endorsement.