State University of New York at Buffalo
This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression.
This is a Phase I/II open-label, efficacy and safety study of bicalutamide in combination with sunitinib in patients with advanced renal cell carcinoma (RCC) who have been treated with a receptor tyrosine kinase inhibitor (RTKI) and experienced disease progression. After entering the study, patients will have sunitinib dosed at the 2 weeks ON and one week OFF scheduled. Dose and schedule modification of sunitinib will be allowed at the discretion of the treating physician. Bicalutamide will be administrated orally at 50 mg daily. This clinical study will utilize the Simon's optimal two stage d…
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be greater than or equal to 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1 4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale 5. Demonstrate adequate organ function 6. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. 7. Subjects of childbearing potential should be willing to use 2…
Antineoplastics, Antiandrogen; CYP3A4 Inhibitor
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