Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT00085020
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2/Neu
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase I, Open-Label Study of the Safety, Tolerability and Pharmacokinetics of GW572016 in Combination With Trastuzumab [Herceptin†]
Status:
COMPLETED
Status Verified Date:
2012-08
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: GW572016 may stop the growth of tumor cells by blocking the enzymes necessary for their 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. Giving GW572016 with trastuzumab may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
PURPOSE: This phase I trial is studying the side effects and best dose of GW572016 when given together with trastuzumab in treating patients with metastatic breast cancer that overexpresses HER2/neu.
Detailed Description:
OBJECTIVES:
Primary
* Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin\^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
* Determine the safety and tolerability of this regimen in these patients.
Secondary
* Determine the pharmacokinetic parameters of this regimen in these patients.
* Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016.
Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin\^®) IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional patients are entered and treated at the OTR.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
Primary
* Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab (Herceptin\^®) in patients with metastatic breast cancer that overexpresses HER2/neu.
* Determine the safety and tolerability of this regimen in these patients.
Secondary
* Determine the pharmacokinetic parameters of this regimen in these patients.
* Determine the clinical response in patients treated with this regimen.
OUTLINE: This is an open-label, multicenter, dose-escalation study of GW572016.
Patients receive oral GW572016 once daily on days 1-28 and trastuzumab (Herceptin\^®) IV over 90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of GW572016 until the optimally tolerated regimen (OTR) is determined. The OTR is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. Once the OTR is determined, 10-18 additional patients are entered and treated at the OTR.
Patients are followed at 28 days.
PROJECTED ACCRUAL: A total of 3-35 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: