Phase 3
N=626
Study Evaluating Interferon And CCI-779 In Advanced Renal Cell Carcinoma
Carcinoma, Renal Cell · Kidney Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00065468 ↗Enrolled (actual)
626
Serious AEs
49.2%
Results posted
Oct 2012
Primary outcome: Primary: Overall Survival (OS) — 7.3; 10.9; 8.4 months — p=0.0252
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Interferon Alfa (Drug); CCI-779 (Drug); Interferon Alfa and CCI-779 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
7.3; 10.9; 8.4 | 0.0252 sig |
| SECONDARY Progression-Free Survival (PFS) |
3.2; 5.6; 4.9 | 0.0042 sig |
| SECONDARY Percentage of Participants With Objective Response |
5.3; 9.1; 9.5 | 0.1361 |
| SECONDARY Percentage of Participants With Clinical Benefit |
16.4; 34.0; 30.0 | <0.0001 sig |
| SECONDARY Duration of Response (DR) |
7.4; 11.1; 9.3 | — |
| SECONDARY Time to Treatment Failure (TTF) |
1.9; 3.7; 2.5 | <0.0001 sig |
| SECONDARY Quality-adjusted Time Without Symptoms or Toxicity (Q-TWiST) |
6.9083; 8.3707; 7.4821 | — |
| SECONDARY European Quality of Life Health Questionnaire (EQ-5D) - Index Score |
0.656; 0.689; 0.689 | — |
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.
Eligibility Criteria
Inclusion Criteria
- This study will be conducted in subjects with histologically confirmed, advanced (stage IV or recurrent disease) RCC who have not received prior systemic therapy for their disease,
Exclusion Criteria
- Subjects with central nervous system (CNS) metastases
- Prior anticancer therapy for RCC
- Prior investigational therapy/agents within 4 weeks of randomization
Data sourced from ClinicalTrials.gov (NCT00065468). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.