Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00093470
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2004-10-06
Brief Title:
Tipifarnib in Treating Patients With Acute Myeloid Leukemia in Remission
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Randomized Study of Farnesyl Transferase Inhibitor R115777 in Acute Myeloid Leukemia AML Patients in Second or Subsequent Remission or in Remission After Primary Induction Failure or Patients Over Age 60 in First Remission
Status:
COMPLETED
Status Verified Date:
2024-03
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:
This randomized phase III trial studies tipifarnib in treating patients with acute myeloid leukemia AML in remission Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth It is not yet known whether tipifarnib is more effective than observation alone in preventing the recurrence of AML
Detailed Description:
PRIMARY OBJECTIVES
I To compare R115777 tipifarnib maintenance therapy to observation only with respect to disease-free survival DFS in patients with AML in second or subsequent complete remission or in complete response CR following primary induction failure
SECONDARY OBJECTIVES
I To compare overall survival of patients in both arms II To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive tipifarnib orally PO twice daily BID on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM B Patients undergo observation only
After completion of study treatment patients are followed up for 5 years
I To compare R115777 tipifarnib maintenance therapy to observation only with respect to disease-free survival DFS in patients with AML in second or subsequent complete remission or in complete response CR following primary induction failure
SECONDARY OBJECTIVES
I To compare overall survival of patients in both arms II To evaluate the long-term safety and toxicity of extended administration of R115777 in AML patients in remission
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM A Patients receive tipifarnib orally PO twice daily BID on days 1-21 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
ARM B Patients undergo observation only
After completion of study treatment patients are followed up for 5 years
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 |
|---|---|---|---|
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |
| NCI-2009-00535 | REGISTRY | None | None |
| E2902 | None | None | None |
| E2902 | OTHER | None | None |
| E2902 | OTHER | None | None |
| U10CA180820 | NIH | None | None |