NCT06222593

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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 design. Investigators will enroll 9 patients in the first stage. If no response is seen, then the trial is terminated for futility. Otherwise, accrual continues to a total of 16 patients. If at most 2 patients respond among the 16 patients, this therapy would warrant further investigation.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Bicalutamide in combination with Sunitinib	Antineoplastics, Antiandrogen; CYP3A4 Inhibitor

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-07-01
• Completion: 2027-07-01
• First posted: 2024-01-24
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States