Study of Bicalutamide with Sunitinib for TKI-Resistant Kidney Cancer
This study is testing a combination of two drugs, bicalutamide and sunitinib, for patients with advanced kidney cancer (renal cell carcinoma) that has gotten worse after treatment with a type of drug called a tyrosine kinase inhibitor (TKI). Researchers want to see how safe and effective this drug combination is. Sunitinib works by blocking certain signals that help cancer grow, and bicalutamide is an antiandrogen. You may be able to join if you are 18 or older, have measurable cancer, and good overall health. The study aims to enroll up to 28 participants and will measure safety and effectiveness over 3 years. The current recruitment status is unclear.
- Study design
- This is an open-label Phase I/II study, meaning both you and your doctors will know which drugs you are receiving. The study plans to enroll up to 28 participants.
- What's involved
- You will take sunitinib for two weeks on and one week off, and bicalutamide daily by mouth. Your doctor may adjust the sunitinib dose. The study will assess outcomes over 3 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and efficacy will be measured at 3 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Roberto Pili, MD · PRINCIPAL_INVESTIGATOR · State University of New York at Buffalo
Who to contact
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What this trial measures
- To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.3 years
Investigators will report the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
- To assess efficacy of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.3 years
Investigators will also report the number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.