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. (ARCC)

NCT00065468 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Pfizer
Phase	Phase 3
Status	COMPLETED
Enrolment	626
Start date	2003-07
Completion	2011-03

Conditions

• Carcinoma, Renal Cell
• Kidney Neoplasms

Interventions

• Interferon Alfa
• CCI-779
• Interferon Alfa and CCI-779

Primary outcomes

• Overall Survival (OS) — Baseline up to Month 80
  Overall survival is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

Countries

United States, Argentina, Australia, Canada, Czechia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Russia, Serbia and Montenegro, Serbia, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom