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Sponsored by: |
Pfizer |
Information provided by: | Pfizer |
ClinicalTrials.gov Identifier: | NCT00083889 |
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).
Condition | Intervention | Phase |
Carcinoma, Renal Cell |
Drug: Interferon-alfa Drug: SU011248 |
Phase III |
ChemIDplus related topics: | Sunitinib Sunitinib malate Interferon alfa-n1 Interferon alfa-2a Interferon alfa-2b Interferons |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma |
Enrollment: | 750 |
Study Start Date: | August 2004 |
Estimated Study Completion Date: | August 2008 |
Estimated Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
2: Active Comparator |
Drug: Interferon-alfa
3 MIU first week, 6 MIU second week, and 9 MIU thereafter three times a week (non-consecutive days) until progression or unacceptable toxicity
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1: Experimental |
Drug: SU011248
50 mg orally daily for 4 weeks and 2 weeks off treatment until progression or unacceptable toxicity
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Show 121 Study Locations |
Pfizer |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
To obtain contact information for a study center near you, click here. 
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Responsible Party: | Pfizer Inc ( Director, Clinical Trial Disclosure Group ) |
Study ID Numbers: | A6181034 |
First Received: | June 3, 2004 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00083889 |
Health Authority: | United States: Food and Drug Administration |
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