Ignite Creation Date:
2024-05-05 @ 9:57 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005624
Status:
COMPLETED
Last Update Posted:
2012-09-25
First Post:
2000-05-02
Brief Title:
CI-994 in Treating Patients With Advanced Myeloma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Multicenter Phase 2 Study of Oral N-Acetyl Dinaline CI-994 in the Treatment of Patients With Advanced Myeloma
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma
PURPOSE Phase II trial to study the effectiveness of CI-994 in treating patients who have advanced myeloma
Detailed Description:
OBJECTIVES I Determine the antitumor activity of CI-994 in patients with advanced myeloma II Determine the response rate response duration and overall survival of this patient population with this treatment regimen III Determine the safety of this treatment in these patients
OUTLINE This is a multicenter study Patients receive CI-994 orally daily Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for 30 days and then every 2 months
PROJECTED ACCRUAL A total of 8-63 patients will be accrued for this study
OUTLINE This is a multicenter study Patients receive CI-994 orally daily Treatment continues in the absence of disease progression or unacceptable toxicity Patients are followed for 30 days and then every 2 months
PROJECTED ACCRUAL A total of 8-63 patients will be accrued for this study
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 |
|---|---|---|---|
| NCI-G00-1758 | OTHER | NCI | None |
| PD-994-04 | OTHER | None | None |