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An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors

NCT00657176 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2008-04-18

No results posted yet for this study

Summary

This is an open-label, non-randomized, single-center, dose-escalation study in patients with advanced solid tumors. Six dose levels (100, 200, 400, 600, 800, and 1000 mg/day) are planned for the study. In this study, OPB-31121's potential for toxic effects will be evaluated in patients with advanced solid tumors to evaluate the recommended dose for use in subsequent studies. The pharmacokinetics and antitumor effect of the compound will also be investigated.

Conditions

Interventions

DRUG

OPB-31121

* 100mg tablet * oral administration, Qd

Sponsors & Collaborators

  • Korea Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yung-Jue Bang, PhD · Division of Hematology and Medical Oncology, Seoul National University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2009-03-31
Completion
2009-06-30

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 NCT00657176 on ClinicalTrials.gov