Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052728
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2003-01-24
Brief Title:
Tipifarnib Plus Tamoxifen in Treating Women With Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial Of Tipifarnib R15777 ZARNESTRA In Combination With Tamoxifen In Subjects With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2005-05
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:
RATIONALE Tipifarnib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Tamoxifen may fight breast cancer by blocking the use of estrogen Combining tipifarnib with tamoxifen may be effective treatment for metastatic breast cancer
PURPOSE This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer
PURPOSE This phase II trial is studying how well giving tipifarnib together with tamoxifen works in treating women with metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of tipifarnib administered with tamoxifen in women with hormone receptor-positive metastatic breast cancer Phase I closed to accrual effective 10232003
Determine the acute and chronic toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the response rate and time to progression in patients treated with this regimen
OUTLINE This is an open-label study of tipifarnib Phase I closed to accrual effective 10232003 Patients are stratified according to benefit from prior hormonal therapy yes vs no phase II
Phase I closed to accrual effective 10232003 Patients receive oral tipifarnib twice daily on days 1-21 Patients also receive oral tamoxifen daily on days 8-18 during course I only and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients are accrued and treated at that dose level in the phase II portion of the study
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 9-12 patients will be accrued for the phase I portion of this study Phase I closed to accrual effective 10232003 A total of 27-40 patients will be accrued for the phase II portion of this study within 3 years
Determine the maximum tolerated dose and recommended phase II dose of tipifarnib administered with tamoxifen in women with hormone receptor-positive metastatic breast cancer Phase I closed to accrual effective 10232003
Determine the acute and chronic toxicity of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the response rate and time to progression in patients treated with this regimen
OUTLINE This is an open-label study of tipifarnib Phase I closed to accrual effective 10232003 Patients are stratified according to benefit from prior hormonal therapy yes vs no phase II
Phase I closed to accrual effective 10232003 Patients receive oral tipifarnib twice daily on days 1-21 Patients also receive oral tamoxifen daily on days 8-18 during course I only and on days 1-28 during all subsequent courses Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of tipifarnib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients are accrued and treated at that dose level in the phase II portion of the study
Patients are followed at 30 days
PROJECTED ACCRUAL A total of 9-12 patients will be accrued for the phase I portion of this study Phase I closed to accrual effective 10232003 A total of 27-40 patients will be accrued for the phase II portion of this study within 3 years
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?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5540 | None | None | None |
| NCI-03-C-0037 | None | None | None |