Actively Recruiting
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
Led by State University of New York at Buffalo · Updated on 2026-04-01
28
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent
- Age 18 years or older at time of consent
- Have measurable disease based on RECIST 1.1
- Have an ECOG performance status of 0 to 2
- Demonstrate adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first dose
- Participants of childbearing potential agree to use two methods of contraception during the study and for 120 days after last dose
- Male participants without prior vasectomy agree to use adequate contraception starting with first dose through 120 days after last dose
- Have archival tumor tissue available or agree to baseline biopsy before treatment
- Have a life expectancy of at least 6 months
You will not qualify if you...
- Currently participating in or recently completed another investigational study within 4 weeks before first dose
- Diagnosis of immunodeficiency or use of systemic steroids or immunosuppressive therapy within 7 days before first dose
- Active tuberculosis infection
- Known additional progressing malignancies requiring treatment, except certain skin cancers and in situ cervical cancer
- Active central nervous system metastases or carcinomatous meningitis
- Active infection requiring systemic therapy
- Any condition or abnormality that may interfere with trial participation or results, as judged by investigator
- Known psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant, breastfeeding, or planning to conceive/father children during study and 120 days after last dose
- Known HIV infection
- Known active Hepatitis B or C infection
- Received live vaccine within 30 days before starting study therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UB/ Great Lakes Cancer Care
Buffalo, New York, United States, 14203
Actively Recruiting
Research Team
R
Roberto Pili, MD/PhD
CONTACT
K
Kirsten Haden
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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