Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101296
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2005-01-07
Brief Title:
Tipifarnib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of R115777 NSC 702818 in Relapsed Refractory or High Risk Myeloid Leukemia
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 some of the enzymes needed for cell growth This phase I trial is studying the side effects and best dose of tipifarnib in treating patients with relapsed or refractory acute myeloid leukemia
Detailed Description:
PRIMARY OBJECTIVES
I To define the maximum tolerated dose MTD of R115777 tipifarnib in patients with relapsed refractory or high risk myeloid leukemias treated according to this regimen
II To assess the toxicity and preliminary assessment of efficacy of R115777 in patients with relapsed refractory or high risk myeloid leukemias
OUTLINE This is a dose-escalation multicenter study
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients achieving a complete response CR receive 2 additional courses beyond CR Patients experiencing relapse after previously achieving CR may receive additional tipifarnib at the current dose level for newly registered patients
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study
I To define the maximum tolerated dose MTD of R115777 tipifarnib in patients with relapsed refractory or high risk myeloid leukemias treated according to this regimen
II To assess the toxicity and preliminary assessment of efficacy of R115777 in patients with relapsed refractory or high risk myeloid leukemias
OUTLINE This is a dose-escalation multicenter study
Patients receive oral tipifarnib twice daily on days 1-7 and 15-21 Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression Patients achieving a complete response CR receive 2 additional courses beyond CR Patients experiencing relapse after previously achieving CR may receive additional tipifarnib at the current dose level for newly registered patients
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 6 months for survival
PROJECTED ACCRUAL A total of 20-30 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 |
|---|---|---|---|
| PHI-47 | None | None | None |
| U01CA062505 | NIH | None | None |
| CDR0000404151 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062505 |