SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma

Pfizer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Renal Cell

Treatments: Drug: Interferon-alfa; Drug: SU011248

Study type: Interventional

Funder types: Industry

Identifiers

NCT00083889

A6181034

Details and patient eligibility

About

The purpose of this study is to test whether SU011248 has activity and is safe compared to interferon-alfa as first-line therapy in patients with metastatic renal cell carcinoma (RCC).

Enrollment: 750 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed renal cell carcinoma of clear cell histology with metastases
• Evidence of measurable disease by radiographic technique
• Eastern Cooperative Oncology Group [ECOG] performance status of 0 or 1

Exclusion criteria

• Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
• History of or known brain metastases
• Serious acute or chronic illness or recent history of significant cardiac abnormality

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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750 participants in 2 patient groups

2

Active Comparator group

Treatment:

Drug: Interferon-alfa

1

Experimental group

Treatment:

Drug: SU011248