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).
A Phase 3, Randomized Study Of SU011248 Versus Interferon-Alfa As First-Line Systemic Therapy For Patients With Metastatic Renal Cell Carcinoma.
Carcinoma, Renal Cell.
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study.
Primary Outcome Measures:
- To compare the progression-free survival in patients treated with SU011248 vs interferon-alfa as first-line systemic therapy
Secondary Outcome Measures:
- To compare the following between the two treatment groups – objective response rate, overall survival, duration of response, patient-reported outcomes, and safety
Eligibility & Criteria
- Ages Eligible for Study: 18 Years and above
- Genders Eligible for Study: Both
- Histologically confirmed renal cell carcinoma of clear cell histology with metastases
- Evidence of measurable disease by radiographic technique
- Male or female, 18 years or older
- ECOG performance status of 0 or 1
- Resolution of all acute toxicities of prior therapies
- Adequate organ function
- Prior systemic (including adjuvant or neoadjuvant) therapy of any kind for RCC
- Major surgery or radiation therapy within 4 weeks
- Severe hemorrhage within 4 weeks
- Diagnosis of a second malignancy within the last 5 years
- History of or known brain metastases, spinal cord compression or carcinomatous meningitis
- Serious acute or chronic illness or recent history of significant cardiac abnormality
- Pre-existing thyroid abnormality with thyroid function that cannot be controlled by medication
- Known HIV or AIDS-related illness
- Current treatment on another clinical trial
Study centre contact information
- Pfizer Investigational Site, St. Leonards, New South Wales, 2065, Australia
- Pfizer Investigational Site, South Brisbane, Queensland, 4101, Australia
- Pfizer Investigational Site, Woodville South, South Australia, 5011, Australia
- Pfizer Investigational Site, East Melbourne, Victoria, 3002, Australia