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Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma or Multiple Myeloma

NCT00511082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2025-04-16

No results posted yet for this study

Summary

* To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients Non-Hodgkin's Lymphoma(NHL) or Multiple Myeloma(MM)
* To determine the potential dose-limiting toxicities and maximum-tolerated dose in patients treated with OPB-31121
* To determine the pharmacokinetics and anti-tumor efficacy of OPB-31121 in patients

Conditions

Interventions

DRUG

OPB-31121

100-mg tablet Dose: OPB-31121 50, 100, 200, 400, 600, 800, and 1000 mg Dosage regimen: ingestion with water after breakfast Treatment period: 4 weeks Mode of Administration: oral administration of OPB-31121 once daily

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Otsuka Beijing Research Institute

    lead INDUSTRY

Principal Investigators

  • Kenny IK Lei, M.D · Department of Clinical Oncology, Prince of Wales Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-12-31
Completion
2010-07-31

Countries

  • Hong Kong

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 NCT00511082 on ClinicalTrials.gov