Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054470
Status:
WITHDRAWN
Last Update Posted:
2012-06-29
First Post:
2003-02-05
Brief Title:
Tipifarnib Plus Trastuzumab in Treating Patients With Metastatic Breast Cancer
Sponsor:
The University of Texas Health Science Center at San Antonio
Organization:
The University of Texas Health Science Center at San Antonio
Study Overview
Official Title:
A Phase II Evaluation Of The Efficacy And Safety Of R115777 NSC702818 A Non-Peptidomimetic Farnesyl Transferase Inhibitor And Trastuzumab In Patients With Advanced Breast Cancer
Status:
WITHDRAWN
Status Verified Date:
2012-06
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 Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining tipifarnib with trastuzumab may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab in treating patients who have metastatic breast cancer
PURPOSE Phase II trial to study the effectiveness of combining tipifarnib with trastuzumab in treating patients who have metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine the antitumor activity of tipifarnib and trastuzumab Herceptin in patients with metastatic breast cancer
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab Herceptin IV over 30-90 minutes on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 18-40 patients will be accrued for this study within 9-20 months
Determine the antitumor activity of tipifarnib and trastuzumab Herceptin in patients with metastatic breast cancer
Determine the safety and tolerability of this regimen in these patients
OUTLINE This is an open-label multicenter study
Patients receive oral tipifarnib twice daily on days 1-21 and trastuzumab Herceptin IV over 30-90 minutes on day 1 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 18-40 patients will be accrued for this study within 9-20 months
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 |
|---|---|---|---|
| UTHSC-IDD-01-44 | OTHER | UTHSCSA IRB | httpsreporternihgovquickSearchP30CA054174 |
| U01CA069853 | NIH | None | None |
| P30CA054174 | NIH | None | None |
| SACI-IDD-01-44 | OTHER | None | None |
| NCI-5330 | OTHER | None | None |