Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005845
Status:
COMPLETED
Last Update Posted:
2013-12-16
First Post:
2000-06-02
Brief Title:
Tipifarnib in Treating Patients With Myelodysplastic Syndromes
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Study of the Farnesyl Transferase Inhibitor R115777 NSC 702818 in Patients With Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This phase I trial studies the side effects and best dose of tipifarnib in treating patients with myelodysplastic syndromes Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth
Detailed Description:
PRIMARY OBJECTIVES
I To determine the toxicity profile and antitumor activity of the farnesyltransferase FTase inhibitor R115777 tipifarnib in patients with myelodysplastic syndrome MDS treated on a one week onone week off schedule
II To determine the effect on R115777 on a one week onone week off schedule on FTase activity prenylation of RAS and other substrates and on downstream effects
OUTLINE This is a dose-escalation study
Patients receive tipifarnib orally PO twice daily BID on weeks 1 3 5 and 7 Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
I To determine the toxicity profile and antitumor activity of the farnesyltransferase FTase inhibitor R115777 tipifarnib in patients with myelodysplastic syndrome MDS treated on a one week onone week off schedule
II To determine the effect on R115777 on a one week onone week off schedule on FTase activity prenylation of RAS and other substrates and on downstream effects
OUTLINE This is a dose-escalation study
Patients receive tipifarnib orally PO twice daily BID on weeks 1 3 5 and 7 Treatment repeats every 8 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U01CA062461 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062461 |
| NCI-2009-01158 | REGISTRY | None | None |
| CDR0000067862 | None | None | None |
| DM01-582 | OTHER | None | None |
| 5625 | OTHER | None | None |