Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045396
Status:
COMPLETED
Last Update Posted:
2013-01-09
First Post:
2002-09-06
Brief Title:
A Phase II Study Of The Farnesyltransferase Inhibitor ZANESTRA R115777 NSC 702818 IND 58359 In Complete Remission Following Induction AndOr Consolidation Chemotherapy In Adults With Poor-Risk Acute Myelogenous Leukemia AML And High-Risk Myelodysplasia MDS
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of the Farnesyltransferase Inhibitor ZARNESTRA Tipifarnib R115777 NSC 702818 IND 58359 in Complete Remission Following Induction andor Consolidation Chemotherapy in Adults With Poor-Risk Acute Myelogenous Leukemia AML and High-Risk Myelodysplasia MDS
Status:
COMPLETED
Status Verified Date:
2013-01
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 patients who have acute myeloid leukemia or myelodysplastic syndrome in first complete remission
Detailed Description:
PRIMARY OBJECTIVES
I To determine the duration of disease-free survival DFS and overall survival OS when ZARNESTRA is administered after intensive induction and consolidation chemotherapy to adults with poor risk acute myelogenous leukemia AML or high-risk myelodysplasia MDS in first complete remission CR
SECONDARY OBJECTIVES
I To determine the tolerability and toxicities of ZARNESTRA when administered in a chronic dosing schedule over a 48 week period to adults in first CR following intensive cytotoxic chemotherapies
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-14 Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 11-15 months
I To determine the duration of disease-free survival DFS and overall survival OS when ZARNESTRA is administered after intensive induction and consolidation chemotherapy to adults with poor risk acute myelogenous leukemia AML or high-risk myelodysplasia MDS in first complete remission CR
SECONDARY OBJECTIVES
I To determine the tolerability and toxicities of ZARNESTRA when administered in a chronic dosing schedule over a 48 week period to adults in first CR following intensive cytotoxic chemotherapies
OUTLINE This is a multicenter study
Patients receive oral tipifarnib twice daily on days 1-14 Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 14-44 patients will be accrued for this study within 11-15 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 |
|---|---|---|---|
| U01CA069854 | NIH | None | httpsreporternihgovquickSearchU01CA069854 |
| J0252 | None | None | None |
| U01CA070095 | NIH | None | None |