NCT01711034

A Phase 1, Open-label, Multiple Dose Escalation Trial to Determine Safety and Tolerability of Once Daily OPB-111077 in Subjects With Advanced Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the safe and tolerable dose level of OPB-111077 for patients with advanced cancer.

Detailed description

The secondary objective of this study is to investigate the pharmacokinetic properties of OPB-111077; the pharmacodynamic effects of OPB-111077; the antitumor activity of OPB-111077 as assessed by RECIST or IMWG Uniform Response Criteria; and to explore whether PET responses correlate with other measures of clinical response.

Conditions

• Solid Tumors

Interventions

Type	Name	Description
DRUG	OPB-111077	Dose escalation phase starting with dose of 100mg tablets on Day 1 and 4, and all remaining days of each 28 day cycle until disease progression or toxicity develops. Dose expansion phase starting with daily dosing of 250mg for 28 day consecutive day cycles.

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-10-22
• Last updated: 2016-04-05

Locations

1 site across 1 country: United States