Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors
This is an open-label, non-randomized, dose-escalation trial in patients with advanced solid tumors. The trial comprises 2 stages: a dose escalation stage at 8 dose levels of 2, 5, 10, 20, 40, 60, 80, and 100 mg/day,and possibly additional intermediate doses, to determine the MTD and recommended dose, and a subsequent 2 parts of expansion stage to investigate the safety profile and antitumor effect of OPB-51602 at the recommended dose.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors|
- safety and tolerability [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment
- Pharmacokinetics [ Time Frame: duration of the treatment ] [ Designated as safety issue: No ]plasma and urinary concentrations of OPB-51602 and its metabolites
- safety and tolerability [ Time Frame: duration of treatment ] [ Designated as safety issue: Yes ]AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in all treatment cycles.
- efficacy [ Time Frame: duration of treatment ] [ Designated as safety issue: No ]Response and progression evaluated using Response Evaluation criteria in solid tumors (RECIST)
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
OPB-51602 at a dose of 2, 5, 10, 20, 40, 60, 80, or 100 mg/day,will be orally administered to subjects once daily for 2 weeks in each cycle of treatment in Dose Escalation Stage.A 2-day treatment-free interval will occur on Days 2 and 3 for PK sampling. Study drug administration will resume on Day 4 and continue until Day 17 in cycle 1.In Expansion stage part 1, OPB-51602 will be administered at recommend dose (4mg) for 3 weeks per cycle 9 2 weeks treatment and 1 week washout). There is also 2-day treatment free interval between Day 1 and Day 4 for PK sampling in cycle 1.In Expansion stage part 2, subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in Cycle 1. The same subjects will be treated at MTD(5mg)from cycle 2 onwards for 4 weeks per cycle.
In expansion stage part 1, up to 20 advanced sold tumor subjects will be investigated the safety profiled and antitumor effect of OPB-51602 at the recommended dose for 3 weeks per cycle（2 weeks treatment and 1 week washout). In the expansion stage part 2, a maximum of 20 subjects with Non-small cell lung cancer (NSCLC), Melanoma or Gastrointestinal Stromal Tumor (GIST) will be treated until an investigational Medicinal product (IMP) efficacious case can be found. subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in cycle 1. After safety and tolerability are confirmed, same subjects will be treated at the MTD(5mg) from cycle 2 onwards as a once-daily oral dose for 4 weeks per cycle to obtain additional information about safety, tolerability and antitumor activity of OPB-51602
|Contact: Cheng Yang||+861085182966 ext 8011||YangCh@obri.otsuka.com|
|National University Hospital (s) PTE LTD.||Recruiting|
|Singapore, Singapore, 119074|
|Contact: Goh Boon Cher, Dr. +65-6779-5555 BoonCherGoh@nuhs.edu.sg|
|Principal Investigator:||Goh Boon Cher, Dr||Department of Haematology-Oncology,National University Hospital|
|Principal Investigator:||Daniel Tan shao Weng, MD, PhD||National Cancer Centre, Singapore|