NCT01184807

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

A Phase 1, Open-label, Non-randomized, Dose-escalation Trial of OPB-51602 in Patients With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Malignant Solid Tumour

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-08-19
• Last updated: 2014-03-26

Locations

2 sites across 1 country: Singapore