A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Sunitinib

Criteria

Inclusion Criteria:

• Cytokine refractory metastatic renal cell carcinoma with clear cell component

• Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy

• Prior nephrectomy

Exclusion Criteria:

• Prior treatment with any systemic therapy other than 1 cytokine therapy

• History of or known brain metastases

• Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start