Phase III Study of Bicalutamide With Sunitinib for Patients With Advanced Renal Cell Carcinoma Resistant to Tyrosine Kinase Inhibitors

What this Trial Is About

Researchers are evaluating the safety and effectiveness of combining bicalutamide with sunitinib in adults who have advanced renal cell carcinoma RCC that has progressed after treatment with receptor tyrosine kinase inhibitors RTKIs. This Phase III open-label study aims to determine if this combination can provide benefit to patients who have not responded to prior RTKI therapies. The trial uses Simons optimal two-stage design to assess early response and decide whether to continue enrollment. Participants will receive bicalutamide orally at 50 mg once daily along with sunitinib taken in cycles of 2 weeks on treatment followed by 1 week off. The dose of sunitinib may be adjusted by the doctor as needed. Treatment will continue through at least four 21-day cycles. The study initially enrolls 9 patients and will proceed to a total of 16 if responses are observed. If few patients respond, the study will end early. During the trial, patients will be closely monitored for safety and treatment effects over a period of up to three years. Evaluations include regular assessments of disease status, side effects, and overall health. Researchers will measure how well patients tolerate the combination therapy and its impact on their cancer. Participation involves scheduled visits for treatment administration, health checks, and laboratory tests until the study completion or earlier withdrawal.

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