SU011248 In The Treatment Of Patients With Bevacizumab (Avastin)-Refractory Metastatic Renal Cell Carcinoma

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00089648

A6181039

Details and patient eligibility

About

The purpose of this study is to test whether sunitinib (SU011248) has activity and is safe in patients with renal cell carcinoma (RCC) who have failed prior therapy with bevacizumab (Avastin) -based treatment.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically proven renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease
• Radiographic evidence of disease progression during or within 3 months of completion of bevacizumab-based treatment
• Prior radical or partial nephrectomy

Exclusion criteria

• Prior treatment with any other anti-angiogenic therapy other than bevacizumab
• Prior systemic treatment for RCC > 2 regimens
• History of or known brain metastases
• Serious acute or chronic illness or recent history of significant cardiac abnormality

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

1

Experimental group

Treatment:

Drug: Sunitinib