Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2026-03-10 @ 11:28 PM
Study NCT ID:
NCT00005967
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
2000-07-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tipifarnib in Treating Patients With Advanced Hematologic Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Dose Finding Study of R115777 (NSC 702818) in Patients With Advanced Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2004-10
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:
Randomized phase I trial to study the effectiveness of tipifarnib in treating patients who have advanced hematologic cancer. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
Detailed Description:
OBJECTIVES:
I. Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies.
II. Determine the safety profile of this drug in this patient population. III. Determine the clinical activity of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels.
Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
I. Determine the relationship between tipifarnib dose and inhibition of farnesylation in malignant cells of patients with advanced hematologic malignancies.
II. Determine the safety profile of this drug in this patient population. III. Determine the clinical activity of this drug in these patients.
OUTLINE: This is a randomized study. Patients are randomized to 1 of 4 dose levels.
Patients receive oral tipifarnib twice daily for 21 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After 1 course of therapy, patients may receive subsequent therapy at the maximum tolerated dose at the investigator's discretion.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: