NCT00511082

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The study is designed as a single-center,open-label,phase 1 dose-escalation study to assess the safety,tolerability,pharmacokinetics, and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM.

Conditions

• Non-Hodgkin's Lymphoma(NHL)
• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-12-01
• Completion: 2010-07-01
• First posted: 2007-08-03
• Last updated: 2025-04-16

Locations

1 site across 1 country: Hong Kong