Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00048503
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2002-11-01
Brief Title:
Study of Tipifarnib as Postconsolidation Therapy for Acute Myeloid Leukemia in Patients 60 Years and Older
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-label Phase 2 Study of the Farnesyl Transferase Inhibitor ZARNESTRA R115777 as Post-consolidation Therapy for Acute Myeloid Leukemia AML in Patients Age 60 Years and Older
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back relapsing Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors FTI It blocks proteins that make leukemia cells grow
Detailed Description:
The study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects 60 years and older with AML in complete remission CR after consolidation therapy Prior to enrollment patients will receive 1 or 2 cycles of induction chemotherapy Patients who attain a CR will receive 1 or 2 cycles of consolidation chemotherapy Patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study Subjects enrolled in the study are treated with tipifarnib A dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events Postconsolidation treatment with tipifarnib continues until the time of relapse death completion of 24 cycles of treatment or discontinuation as advised by study doctor
Tipifarnib film coated compressed tablets containing 100 mg active drug will be administered orally at a dose of 300 mg three 100 mg film coated tablets taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months
Tipifarnib film coated compressed tablets containing 100 mg active drug will be administered orally at a dose of 300 mg three 100 mg film coated tablets taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 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