Trials / Unknown
UnknownNCT00657176
An Open-Label Phase-1 Study of OPB-31121 in Patients With Advanced Solid Tumors
A Phase 1, Open-Label, Non-Randomized Study of OPB-31121 in Patients With Advanced Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- Sponsor
- Korea Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | OPB-31121 | * 100mg tablet * oral administration, Qd |
Timeline
- Start date
- 2008-03-01
- Primary completion
- 2009-03-01
- Completion
- 2009-06-01
- First posted
- 2008-04-14
- Last updated
- 2008-04-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT00657176. Inclusion in this directory is not an endorsement.