A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors
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
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
safety and tolerability
AEs, vital signs, body weight, ECG, clinical laboratory tests, and ECOG performances status in the first cycle of treatment
3 weeks
Yes
Goh Boon Cher, Dr
Principal Investigator
Department of Haematology-Oncology,National University Hospital
Singapore: Health Sciences Authority
266-09-801-01
NCT01184807
December 2009
October 2013
Name | Location |
---|