CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 626 enrolled
Drug / intervention
Interferon Alfa +2 moredrug
Likely dose
Interferon alfa 18 MU subcutaneously three times per week; CCI-779 25 mg intravenously once per week (monotherapy arms) or CCI-779 15 mg intravenously once per week with interferon alfa 6 MU subcutaneously three times per week (combination arm)AI-extracted
Key inclusion· 2
  • ✓Histologically confirmed advanced renal cell carcinoma (stage IV or recurrent disease)
  • ✓No prior systemic therapy for RCC
Key exclusion· 3
  • ✕CNS metastases
  • ✕Prior anticancer therapy for RCC
  • ✕Prior investigational therapy within 4 weeks of randomization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00065468
NCT00065468Phase 3Completed
CompareCT.gov

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.

Pfizer·interventional·Posted Jul 25, 2003·Updated Oct 25, 2012

In Brief

A Phase 3 clinical trial evaluating Interferon Alfa, CCI-779, and 1 other intervention for Carcinoma, Renal Cell and Kidney Neoplasms. Completed, enrolled 626 participants across 153 sites in 25 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell, Kidney Neoplasms
Countries, Argentina, Australia, Canada, Czechia, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Mexico, Netherlands, Poland, Russia, Serbia, Serbia and Montenegro, Slovakia, South Africa, Spain, Sweden, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 25, 2003
Enrollment StartJul 1, 2003
Primary CompletionJun 1, 2006
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 22.9 years ago

Interventions

Interferon Alfadrug

Interferon alfa (Roferon) 3 MU given Sub Cutaneously three time /week for the first week, 9 MU given Sub Cutaneously three time /week for the second week, 18 MU given Sub Cutaneously three time /week thereafter.

CCI-779drug

25 mg of CCI-779 given Intra Venously once per week

Interferon Alfa and CCI-779drug

15 mg of CCI-779 given Intra Venously once per week; 6 MU of IFN alfa (Roferon) given Sub Cutaneously three time /week