Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511082
Status:
UNKNOWN
Last Update Posted:
2008-07-02
First Post:
2007-08-02
Brief Title:
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma or Multiple Myeloma
Sponsor:
Otsuka Beijing Research Institute
Organization:
Otsuka Beijing Research Institute
Study Overview
Official Title:
Phase 1 Study of OPB-31121 in Patients With Relapsed or Refractory Non-Hodgkins Lymphoma or Multiple Myeloma
Status:
UNKNOWN
Status Verified Date:
2008-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients Non-Hodgkins LymphomaNHL or Multiple MyelomaMM
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
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-centeropen-labelphase 1 dose-escalation study to assess the safetytolerabilitypharmacokinetics and anti-tumor efficacy of OPB-31121 in patients with relapsed or refractory NHL or MM
To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients NHL or 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
To investigate the safety and tolerability of OPB-31121 following repeated oral administration of OPB-31121 in patients NHL or 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 252-07-801-01 | None | None | None |