Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer
|ClinicalTrials.gov Identifier: NCT01423903|
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : January 15, 2014
|Condition or disease||Intervention/treatment||Phase|
|Advanced Cancer||Drug: OPB-51602||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once-Daily OPB-51602 in Subjects With Advanced Cancer|
|Study Start Date :||February 2010|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Subjects with advanced solid tumors will be treated with OPDC-51602 once daily by mouth
A cycle will consist of 28 days of OPB-51602 be taken by study subjects daily by mouth for every day of each 28 day cycle.
- To determine the safety and tolerability of OPB-51602 [ Time Frame: Weekly for first cycle, then every 2 weeks (on average up to 8 weeks). ]AEs, vital signs, body weight, ECGs, clinical laboratory tests, and performance status will be assessed.
- To determine the pharmacokinetics of OPB-51602 and to determine the MTD of OPB-51602 [ Time Frame: 28 days ]The following PK parameters (Cmax, tmax, AUC₀₋t, AUCtau, CLss/F and t½,z) will be determined using a non-compartmental approach for OPB-51602 and selected metabolites after single (Cycle 1, Day 1) and multiple daily doses (Cycle 2, Day 1).
- Pharmacodynamic profile: [ Time Frame: 28 days ]Study drug effects on STAT-3 phosphorylation will be assessed in PBMCs of study subjects in the dose escalation and expansion stages.
- Antitumor effects: [ Time Frame: Every 2 cycles (on average 8 weeks). ]Treatment response and/or disease progression in subjects with measurable disease will be evaluated after every 2 cycles using Response Evaluation Criteria in Solid Tumors (RECIST₉).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423903
|United States, Florida|
|Sarasota, Florida, United States, 34232|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02114|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Agnes Elekes, M.D.||Otsuka Pharmaceutical Development & Commercialization, Inc.|