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
All content and media on the HealthEngine Blog is created and published online for informational purposes only. It is not intended to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the guidance of your doctor or other qualified health professional with any questions you may have regarding your health or a medical condition. Never disregard the advice of a medical professional, or delay in seeking it because of something you have read on this Website. If you think you may have a medical emergency, call your doctor, go to the nearest hospital emergency department, or call the emergency services immediately.