Phase I Dose Escalation Study of VS-6063 in Japanese Subjects With Non-Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT01943292|
Recruitment Status : Completed
First Posted : September 16, 2013
Results First Posted : November 20, 2015
Last Update Posted : March 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Non Hematologic Cancers||Drug: Defactinib||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Dose Escalation Study to Evaluate the Safety and Pharmacokinetics of VS-6063, a Focal Adhesion Kinase Inhibitor, in Japanese Subjects With Non-Hematologic Malignancies|
|Actual Study Start Date :||September 2, 2013|
|Actual Primary Completion Date :||June 9, 2014|
|Actual Study Completion Date :||June 9, 2014|
Oral defactinib (VS-6063) administered twice a day (BID) during a 21 day cycle.
Other Name: VS-6063
- Assess the Safety and Tolerability of Defactinib (VS-6063) in Japanese Subjects With Non-hematologic Malignancies [ Time Frame: From start of treatment to end of treatment, an expected average of 12 weeks ]
A composite by dose level to include incidence of AEs, SAEs, dose interruptions and dose reductions as a measure of safety and tolerability. Abnormal Clinical significant laboratory results, ECG measurements, vital signs measurement, physical examination findings, and ECOG performance status were captured as adverse events.
The severity of AEs were evaluated according to CTCAE (Common Toxicity Criteria for Adverse Effects) 4.03
- Define the Maximum Tolerated Dose (MTD), if Achieved, and Establish the Recommended Phase 2 Dose (RP2D) of Defactinib (VS-6063) in Japanese Subjects. [ Time Frame: From start of treatment to end of cycle 1 (21 day cycles) ]The RP2D will be determined based on the MTD of defactinib (VS-6063) as determined by number of participants with dose limiting toxicities (DLTs) related to defactinib.
- Assess the Pharmacokinetics, Metabolism and Elimination of Defactinib (VS-6063) in Plasma and Urine. [ Time Frame: Time points at Day 1 and Day 15 in Cycle 1 ]PK parameters, including but not limited to plasma concentration, AUC (Area Under Curve) 0-t, Cmax, Tmax, and T1/2. Total 24-hour urine output will be collected in conjunction with PK sampling to assess the elimination of defactinib (VS-6063) and its potential metabolites.
- Evaluate the Efficacy (Response Rate and Progression-free Survival) of Subjects Treated With Defactinib (VS-6063). [ Time Frame: Every 8 weeks up to end of treatment, an expected average of 12 weeks ]Response rate and progression-free survival, as determined by Response Evaluation Criteria In Solid Tumors (RECIST), version 1.1
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): NCT01943292
|Kinki University Hospital|
|Study Chair:||Hagop Youssoufian, m||Verastem, Inc.|