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

NCT02250170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2019-09-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

OPB-111077

Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on \& 3 days-off (21 days=1cycle)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Doyoun Oh, MD · Seoul National University Hospital

  • Jeehyun Kim, MD · Seoul National University Bundang Hospital

  • Sungbae Kim, MD · Asan Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-23
Primary Completion
2019-03-08
Completion
2019-03-08

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02250170 on ClinicalTrials.gov