Randomized Parallel Group Phase II Clinical Study of Sorafenib/Interferon Combination Therapy and Sunitinib Monotherapy for Advanced Renal Cell Carcinoma

UMIN ID: UMIN000001995

Registered date:21/05/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Advanced renal cell carcinoma
• Date of first enrollment: 2009/08/01
• Target sample size: 200
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Four-week subcutaneous administration of Sumiferon 6 million units three times a week is followed by oral administration of sorafenib 400 mg bid. The combination therapy with Sumiferon and sorafenib is continued until the disease status is assessed as PD.
Four-week oral administration of sunitinib 50 mg qd is followed by 2-week drug withdrawal: this 6-week course is repeated until the disease status is PD.

Outcome(s)

• Primary Outcome: Progression-free survival

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1.Patients who have received systemic therapy for renal carcinoma 2.Patients who completed the surgery or radiotherapy for renal carcinoma less than 4 weeks before initiation of the present study 3.Patients suffering from multiple cancers within last 5 years, excepting those who received appropriate treatment for the following a. Basal cell carcinoma or squamous cell carcinoma of skin b. Uterine cervix carcinoma, gastric cancer or large intestine carcinoma (in situ) 4. Patients who are diagnosed as having cerebral metastasis, meningeal metastasis, spinal cord compression, or meningitis carcinomatosa 5. Patients who are found to have either of the following diseases within 12 months before initiation of the present study Myocardial infarction, severe or unstable angina, coronary or peripheral arterial bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism 6. Patients with arrhythmia (Grade 2 or severer according to the CTCAE ver. 3.0) or atrial fibrillation (regardless of Gragde), or male patients with QTc interval prolonged over 450 msec or female patients with QTc interval prolonged over 470 msec

Related Information

• Primary Sponsor: Osaka Urological Oncology Research Group
• Source(s) of Monetary Support: Osaka Kidney Foundation