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.

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NCT06222593

Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC

Recruiting
PHASE1Ages 18+InterventionalTreatment
State University of New York at Buffalo
~28 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Bicalutamide in combination with Sunitinib

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Measured over 3 years
+1 more outcome measured
Carcinoma, Renal Cell
1 sites across 1 states
New York1
  • Roberto Pili, MD · PRINCIPAL_INVESTIGATOR · State University of New York at Buffalo

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  • 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.