Study Of SU011248 Plus Gefitinib (Iressa) In Patients With Advanced Renal Cell Carcinoma

Completed · Phase 1/Phase 2

Conditions studied: Carcinoma, Renal Cell

In brief

To assess the maximum tolerated dose and overall safety and tolerability of sunitinib \[SU011248\] administered in combination with gefitinib (Iressa) for the treatment of patients with metastatic renal cell carcinoma (Phase 1). To assess antitumor activity of the combination of gefitinib and sunitinib (Phase 2).

Key facts

Study ID

NCT00113529

Run by

Pfizer

People needed

42

Starts

2004-10-01

Expected to finish

2008-10-01

Last updated by the study team

2011-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed renal cell carcinoma with metastases
• Evidence of unidimensionally measurable disease
• Failure of 1 prior immunotherapy or no prior systemic therapy for metastatic RCC

You may not qualify if…

• RCC without any clear (conventional) cell component
• History of or known brain metastases
• Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study entry

Where it is running

• Pfizer Investigational Site — Ann Arbor, Michigan, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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