Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085020
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2004-06-10
Brief Title:
GW572016 and Trastuzumab in Treating Patients With Metastatic Breast Cancer That Overexpresses HER2Neu
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
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 HER2neu
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 HER2neu
Detailed Description:
OBJECTIVES
Primary
Determine the optimally tolerated regimen of GW572016 when administered with trastuzumab Herceptin in patients with metastatic breast cancer that overexpresses HER2neu
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 HER2neu
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:
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 |
|---|---|---|---|
| GSK-EGF10023 | None | None | None |
| UCLA-0305039 | None | None | None |