Phase 1, Open-label Trial to Determine Safety of OPB-51602 in Subjects With Advanced Cancer
The purpose of this study is to determine whether OPB-51602 is safe and tolerable when given daily by mouth to subjects with advanced solid tumors.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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). ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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). ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||February 2010|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
This study is based on data that support a role for the signal transducer and activator of transcription (STAT) family of proteins in oncogenesis. One of the mechanisms of action of OPB-51602 includes inhibition of STAT3 phosphorylation. Therefore OPB-51602 is expected to be active as an anti-cancer drug. This first-in-human study will characterize the safety profile of OPB-51602, evaluate the pharmacokinetics of OPB-51602, identify a recommended phase II dose, and obtain preliminary efficacy data, in subjects with advanced cancers for whom there is no standard treatment available.
|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.|