Sunitinib Malate Schedule 4/2 vs. Sunitinib Malate Continuous Dosing As First-Line Therapy For Metastatic Renal Cell Cancer (RCC)
Completed · Phase 2
Conditions studied: Carcinoma, Renal Cell
In brief
This trial has two parts. The purpose of the first part of the trial is to determine the doses of 2 drugs, sunitinib malate and interferon alfa-2b, that can be given safely in combination. This part is currently closed to enrollment. The purpose of the second part of the trial is to see if sunitinib malate given on a 4/2 schedule (4 weeks on treatment, 2 weeks off treatment cycle) is any better at delaying progression of renal cell cancer than sunitinib malate given on a continuous dosing schedule. The trial will also determine the number of patients whose cancer responds to the treatments, whether life of patients can be extended, what the side effects are of the treatments, how bothersome disease or treatment-related symptoms are to patients, and whether tests can be found that will predict which patients may or may not respond to these treatments in the future.
Key facts
- Study ID
- NCT00267748
- Run by
- Pfizer
- People needed
- 317
- Starts
- 2005-12-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2011-09-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Advanced renal cell carcinoma of clear cell origin or a component of clear cell histology.
- Measurable disease
You may not qualify if…
- Prior systemic therapy of any kind for advanced renal cell cancer
- History of brain metastases
- Uncontrolled hypertension
Where it is running
- Pfizer Investigational Site — Little Rock, Arkansas, United States
- Pfizer Investigational Site — Anaheim, California, United States
- Pfizer Investigational Site — Baldwin Park, California, United States
- Pfizer Investigational Site — Bellflower, California, United States
- Pfizer Investigational Site — Duarte, California, United States
- Pfizer Investigational Site — Fontana, California, United States
- Pfizer Investigational Site — Irvine, California, United States
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Los Angeles, California, United States
- Pfizer Investigational Site — Panorama City, California, United States
- Pfizer Investigational Site — Riverside, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — San Diego, California, United States
- Pfizer Investigational Site — Woodland Hills, California, United States
- Pfizer Investigational Site — Aurora, Colorado, United States
- Pfizer Investigational Site — Boulder, Colorado, United States
- Pfizer Investigational Site — Boulder, Colorado, United States
- Pfizer Investigational Site — Colorado Springs, Colorado, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Denver, Colorado, United States
- Pfizer Investigational Site — Lakewood, Colorado, United States
- Pfizer Investigational Site — Littleton, Colorado, United States
- Pfizer Investigational Site — Lone Tree, Colorado, United States
- Pfizer Investigational Site — Hot Springs, Arkansas, United States
Full record on ClinicalTrials.gov
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