Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065468
Status:
COMPLETED
Last Update Posted:
2012-10-25
First Post:
2003-07-24
Brief Title:
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Phase 3 Three-Arm Randomized Open-Label Study Of Interferon Alfa Alone CCI-779 Alone And The Combination Of Interferon Alfa And CCI-779 In First-Line Poor-Prognosis Subjects With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-09
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:
ARCC
Brief Summary:
The primary objective of this study is efficacy The primary efficacy endpoint of this study is a comparison of the overall survival of subjects treated with CCI-779 Temsirolimus administered intravenously IV once weekly and the combination of CCI-779 administered IV once weekly with Interferon Alfa IFN alfa subcutaneously SC three times per week TIW compared with the overall survival of subjects treated with IFN alfa SC TIW alone in poor-prognosis subjects with advanced RCC
Detailed Description:
None
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