At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 750 enrolled
Drug / intervention
Interferon-alfa +1 moredrug
Likely dose
SU011248 50 mg orally daily for 4 weeks, then 2 weeks off (repeating cycle)AI-extracted
Key inclusion· 4
- ✓Histologically confirmed renal cell carcinoma of clear cell histology
- ✓Metastatic disease
- ✓Measurable disease by radiographic imaging
- ✓ECOG performance status 0 or 1
Key exclusion· 3
- ✕Prior systemic therapy for RCC (adjuvant, neoadjuvant, or otherwise)
- ✕History of or known brain metastases
- ✕Serious acute or chronic illness or recent significant cardiac abnormality
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma
In Brief
A Phase 3 clinical trial evaluating Interferon-alfa and SU011248 for Carcinoma, Renal Cell. Completed, enrolled 750 participants across 123 sites in 11 countries.
Detailed Summary
The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCarcinoma, Renal Cell
CountriesAustralia, Brazil, Canada, France, Germany, Italy, Poland, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2004
Enrollment StartAug 2004
Primary CompletionSep 2008
TodayJul 2026
First PostedJun 4, 2004
Enrollment StartAug 1, 2004
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 22.1 years ago
Interventions
Interferon-alfadrug
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
SU011248drug
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity