Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma.
|ClinicalTrials.gov Identifier: NCT02004028|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : April 11, 2018
|Condition or disease||Intervention/treatment||Phase|
|Malignant Pleural Mesothelioma||Drug: VS-6063||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||38 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Window of Opportunity Phase II Study of the FAK Inhibitor Defactinib VS-6063 in Participants With Surgical Resectable Malignant Pleural Mesothelioma.|
|Study Start Date :||December 2013|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Experimental: VS-6063 (defactinib)
Administered orally (BID) for 12, 21 or 35 days (+/- 2 days)
Other Name: defactinib
- Assess biomarker responses to VS-6063 in tumor tissue [ Time Frame: From Baseline to 12, 21 or 35 days (+/- 2 days) post-treatment ]To determine biomarker responses to the Focal Adhesion Kinase (FAK) inhibitor, VS-6063 (defactinib), in Malignant Pleural Mesothelioma (MPM).
- Evaluate the safety of VS-6063 (defactinib) [ Time Frame: Start of treatment through 30 days after the end of treatment, expected average of 6-8 weeks ]Adverse events will be graded by the CTCAE (Common Terminology Criteria for Adverse Events) 4.0 and summarized according to the worst grade observed since the first treatment dose.
- Evaluate the pharmacokinetics of VS-6063 (defactinib) [ Time Frame: Day 11 and Day 12, Day 21 and 28, or Day 35 and 42 (+/-2) days post-treatment ]PK (pharmacokinetic) parameters will include but not limited to peak and trough concentrations and AUC (area under curve), clearance, and elimination half-life will be characterized by average and variation summaries in the population.
- To evaluate the tumor response to VS-6063 (defactinib) [ Time Frame: Baseline and 12, 21 or 35 (+/-2) days post-treatment ]Tumor response will be assessed by Recist 1.1 modified for mesothelioma. The response rate will be reported with 95% exact confidence intervals based on the exact binomial distribution.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02004028
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Study Chair:||Raphael Bueno, M.D.||Brigham and Women's Hospital|