Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00050141
Status:
COMPLETED
Last Update Posted:
2013-02-01
First Post:
2002-11-22
Brief Title:
Study of Letrozole Plus Tipifarnib or Placebo in the Treatment of Advanced Breast Cancer
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomised Blinded Phase 2 Study of Letrozole Plus the Farnesyl Transferase Inhibitor ZARNESTRA TM R115777 and Letrozole Plus Placebo in the Treatment of Advanced Breast Cancer After Antiestrogen Therapy
Status:
COMPLETED
Status Verified Date:
2013-01
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 the addition of tipifarnib to standard letrozole therapy leads to a better response to treatment for your cancer in comparison to letrozole plus a placebo Tipifarnib belongs to a class of drugs called Farnesyl Transferase Inhibitors FTI It blocks proteins that make cancer cells grow
Detailed Description:
This clinical study involves two groups of patients with advanced breast cancer One group 23rds of all the patients will be taking tipifarnib in combination with another anticancer drug called letrozole and the other group 13rd of all the patients will be taking letrozole plus a placebo an inactive substance given in the same form as a real drug The assignment to one of these two groups will be by chance like flipping a coin Unless the need arises neither the patient nor the study staff will know whether the patient is receiving tipifarnib with the letrozole Comparisons between the two groups will be made for patients who have achieve a confirmed Complete Response CR or Partial Response PR The interval between the date of randomization and the earliest date of disease progression will also be assessed The study will include evaluations of safety and tolerability Patients should expect their participation in this trial to last a minimum of 4 to 8 weeks Their participation could continue for several months or beyond a year depending on how their disease responds to the treatment After completing study treatment patients will be asked to attend for an End of Treatment visit and then a posttreatment Follow-up visit 4 to 6 weeks after stopping the medication Patients will be randomly assigned to treatment with either 25 mg letrozole once daily plus placebo to match tipifarnib twice daily or 25 mg letrozole once daily plus 300 mg tipifarnib twice daily Both tipifranib and matching placebo will be given in 28-day cycles of 21 days of treatment followed by 7 days rest All patients will receive continuous treatment with letrozole
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