Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma.
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|