Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027872
Status:
COMPLETED
Last Update Posted:
2013-03-25
First Post:
2001-12-07
Brief Title:
Tipifarnib in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Farnesyl Transferase Inhibitor R115777 Zarnestra R115777 Zarnestra Tipifarnib R115777 NSC 702818 in Elderly Patients With Previously Untreated Poor-Risk Acute Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2013-03
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:
Tipifarnib may stop the growth of cancer cells by blocking the enzymes necessary for their growth Phase II trial to study the effectiveness of tipifarnib in treating older patients who have previously untreated acute myeloid leukemia
Detailed Description:
PRIMARY OBJECTIVES
I To determine the complete response rate of R115777 tipifarnib in previously untreated acute myeloid leukemia AML in a elderly patients age 75 and b patients age 65 with AML preceded by myelodysplastic syndrome MDS using a chronic dosing schedule
SECONDARY OBJECTIVES
I To determine progression-free and overall survival in patients with previously untreated AML treated with R115777 using a chronic dosing schedule
II To determine the duration of response in patients with previously untreated AML treated with R115777 using a chronic dosing schedule
III To determine the effect of R115777 on the phosphorylation of mitogen-activated protein kinase MAPK and phosphatidylinositol-45-bisphosphate 3-kinase catalytic subunit alpha PI3K in leukemic cells
IV To determine the effect of R115777 on processing of the farnesylated protein HDJ-2
V To determine the toxicities of R115777 when given in a chronic dosing schedule
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Patients with a complete or partial response hematologic improvement or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity Patients with a complete response after the second course of therapy receive 2 additional courses of therapy
Patients are followed for survival
PROJECTED ACCRUAL A total of 125 patients will be accrued for this study within 11-17 months
I To determine the complete response rate of R115777 tipifarnib in previously untreated acute myeloid leukemia AML in a elderly patients age 75 and b patients age 65 with AML preceded by myelodysplastic syndrome MDS using a chronic dosing schedule
SECONDARY OBJECTIVES
I To determine progression-free and overall survival in patients with previously untreated AML treated with R115777 using a chronic dosing schedule
II To determine the duration of response in patients with previously untreated AML treated with R115777 using a chronic dosing schedule
III To determine the effect of R115777 on the phosphorylation of mitogen-activated protein kinase MAPK and phosphatidylinositol-45-bisphosphate 3-kinase catalytic subunit alpha PI3K in leukemic cells
IV To determine the effect of R115777 on processing of the farnesylated protein HDJ-2
V To determine the toxicities of R115777 when given in a chronic dosing schedule
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 Patients with a complete or partial response hematologic improvement or stable disease continue treatment every 29-63 days in the absence of disease progression or unacceptable toxicity Patients with a complete response after the second course of therapy receive 2 additional courses of therapy
Patients are followed for survival
PROJECTED ACCRUAL A total of 125 patients will be accrued for this study within 11-17 months
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 |
|---|---|---|---|
| UMGCC 0116 | None | None | None |
| U01CA069854 | NIH | None | None |
| U01CA070095 | NIH | None | httpsreporternihgovquickSearchU01CA070095 |