Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031278
Status:
COMPLETED
Last Update Posted:
2011-05-30
First Post:
2002-02-28
Brief Title:
Safety And Efficacy Study Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase III Open Label Multi-Center Study For The Evaluation Of The Combination Of CpG 7909 And Herceptin In Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-05
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 combination of CPG 7909 and Herceptin is safe and effective in the treatment of metastatic breast cancer
RATIONALE There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin This Phase III study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy
SCHEDULE Patients will receive CPG 7909 weekly for up to six months
RATIONALE There is preclinical data that supports the hypothesis that CPG 7909 may potentiate the action of Herceptin This Phase III study is designed to evaluate the safety and efficacy of the combination treatment of CPG 7909 and Herceptin in patients with metastatic breast cancer who have previously been treated with Herceptin and chemotherapy
SCHEDULE Patients will receive CPG 7909 weekly for up to six months
Detailed Description:
Phase II part of study not initiated because the development plan modified the route of administration to subcutaneous injection
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 |
|---|---|---|---|
| C005 | None | None | None |
| A8501020 | None | None | None |