Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050154
Status:
COMPLETED
Last Update Posted:
2010-04-27
First Post:
2002-11-22
Brief Title:
Study of Tipifarnib in Patients With High-Risk Myelodysplastic Syndrome MDS
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
An Open-Label Phase 2 Study to Evaluate the Efficacy and Safety of the Farnesyl-Transferase Inhibitor ZARNESTRAtm R115777 in Subjects With High-Risk Myelodysplastic Syndrome MDS
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 characterize the hematological response rate as well as other parameters of efficacy and safety induced by tipifarnib in patients with high-risk myelodysplastic syndrome MDS Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors FTI It blocks proteins that make cancer cells grow
Detailed Description:
Treatment with tipifarnib will be given during one or more periods of time called cycles Each cycle will be 28 days long and patients will take tipifarnib for the first 21 days of each cycle No medication will be taken during the last 7 days of each cycle On day 1 and 15 of each cycle patients will be asked about any side effects that have occurred since their last visit Blood will drawn for routine testing to evaluate any possible effects of tipifarnib on white blood cells or on specific elements that can be measured in the blood The study doctor will decide if any bone marrow aspirates or biopsies should be taken Tipifarnib will be given until the patients disease worsens or they develop unacceptable side effects or until they withdraw consent to receive tipifarnib When tipifarnib treatment is ended or if the patient leaves the study early they will be asked to come in for a final visit The study doctor will decide if any blood draws bone marrow aspirates or biopsies need to be taken
Tipifarnib is 300 mg administered orally as three 100 mg tablets twice daily for the first 21 days in each 28-day cycle Tipifarnib will be administered until the patient discontinues treatment due to disease progression or unacceptable toxicity
Tipifarnib is 300 mg administered orally as three 100 mg tablets twice daily for the first 21 days in each 28-day cycle Tipifarnib will be administered until the patient discontinues treatment due to 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