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|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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.|