RecruitingPhase 1Phase 2NCT06222593

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

A Phase I/II Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With Receptor Tyrosine Kinase Inhibitor Resistant Renal Cell Carcinoma


Sponsor

State University of New York at Buffalo

Enrollment

28 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a drug called bicalutamide (a hormone-blocking drug) to sunitinib (a targeted cancer drug) can help treat kidney cancer (renal cell carcinoma) that has stopped responding to other targeted therapies. **You may be eligible if...** - You are 18 years old or older - You have kidney cancer that is measurable on imaging - Your cancer has stopped responding to prior targeted therapies (TKIs) - Your overall health status is acceptable (ECOG 0–2) - Your organ function (blood counts, liver, kidneys) is adequate - You are willing to use contraception during and for 4 months after treatment **You may NOT be eligible if...** - You have active brain metastases - You have an immune system disorder or are on immunosuppressive drugs - You have active tuberculosis, hepatitis B, hepatitis C, or HIV - You are pregnant or breastfeeding - You received a live vaccine within the last 30 days - You have another active or progressing cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBicalutamide in combination with Sunitinib

Antineoplastics, Antiandrogen; CYP3A4 Inhibitor


Locations(1)

UB/ Great Lakes Cancer Care

Buffalo, New York, United States

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NCT06222593


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