NCT02250170

Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

A Phase 1, Open-label, Non-Randomized, Dose Escalation Trial to Evaluate Safety and Biomarker of OPB-111077 in Subjects With Advanced Solid Tumor

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Korea Otsuka Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This open-label, non-randomized trial will comprise of 2 parts. A dose escalation part will characterize the safety, biomarker and pharmacokinetics of OPB-111077 in advanced solid tumor. Subsequently, an expansion part will further evaluate the biomarker, safety, pharmacokinetics and antitumor activity of OPB-111077 in selected tumor types.

Detailed description

This trial is designed to determine the safety, tolerability, maximum tolerated dose and recommended dose of OPB-111077 administered orally 4-days on and 3-days off (3 weeks/cycle) to subjects with advanced solid tumor in the dose escalation part so that biomarkers, efficacy, and others can be evaluated at the recommended dose in an expeditious manner in the expansion part. The dose escalation part employs a 3+3 escalation design as a standard dose escalation design for a small sample size.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	OPB-111077	Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle)

Timeline

• Start date: 2014-10-23
• Primary completion: 2019-03-08
• Completion: 2019-03-08
• First posted: 2014-09-26
• Last updated: 2019-09-10

Locations

3 sites across 1 country: South Korea