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

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: SU011248

Study type: Interventional

Funder types: Industry

Identifiers

NCT00077974

A6181006

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 1 patient group

1

Experimental group

Treatment:

Drug: SU011248