Trials / Terminated
TerminatedNCT02004028
Window of Opportunity Study of VS-6063 (Defactinib) in Surgical Resectable Malignant Pleural Mesothelioma Participants
An Open Label Window of Opportunity Phase II Study of the FAK Inhibitor Defactinib VS-6063 in Participants With Surgical Resectable Malignant Pleural Mesothelioma.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Verastem, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is an open label neoadjuvant (treatment with VS-6063 prior to mesothelioma surgery) study in subjects with malignant pleural mesothelioma who are eligible for surgery. Subjects will receive VS-6063 (defactinib) 400 mg twice daily for 12, 21, or 35 days or 100 mg formulation twice daily for 21 days. Pre- and post-treatment biopsies and blood samples will be collected. The purpose of this study is to assess biomarker responses from tumor tissue. The safety, pharmacokinetics, and tumor response rate to VS-6063 (defactinib) will be also be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VS-6063 |
Timeline
- Start date
- 2013-12-12
- Primary completion
- 2019-06-19
- Completion
- 2019-06-19
- First posted
- 2013-12-06
- Last updated
- 2024-02-20
- Results posted
- 2024-02-20
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02004028. Inclusion in this directory is not an endorsement.