Phase 1, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

June 30, 2013

Study Completion Date

June 30, 2013

Conditions
Malignant Solid Tumour
Interventions
DRUG

OPB-51602

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.

Trial Locations (2)

119074

National University Hospital (s) PTE LTD., Singapore

160610

National Cancer Centre, Department of Medical Oncology, Singapore

All Listed Sponsors
lead

Otsuka Beijing Research Institute

INDUSTRY