Actively Recruiting
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
Led by State University of New York at Buffalo · Updated on 2026-04-01
28
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
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 I/II 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 Simon's 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.
CONDITIONS
Brief 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...
- Be willing and able to provide written informed consent for the trial.
- Be 18 years of age or older at the time of signing informed consent.
- Have measurable disease based on RECIST 1.1 criteria.
- Have an Eastern Cooperative Oncology Group (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 starting treatment.
- Participants of childbearing potential must agree to use two methods of contraception during the study and for 120 days after the last dose.
- Male participants without prior vasectomy must agree to use effective contraception from the first dose through 120 days after the last dose.
- Have archival tumor tissue available or be willing to undergo a baseline biopsy before treatment.
- Have a life expectancy of at least 6 months.
You will not qualify if you...
- Currently participating in another investigational study or have received investigational therapy or devices within 4 weeks before starting treatment.
- Have immunodeficiency or have received systemic steroids or immunosuppressive therapy within 7 days before starting treatment.
- Have active tuberculosis.
- Have another progressing malignancy requiring active treatment, except certain skin cancers or in situ cervical cancer.
- Have known active central nervous system metastases or carcinomatous meningitis.
- Have an active infection requiring systemic therapy.
- Have conditions or therapies that could interfere with trial participation or safety, as judged by the investigator.
- Have psychiatric or substance abuse disorders interfering with study cooperation.
- Are pregnant, breastfeeding, or planning to conceive or father children during the study and for 120 days after the last dose.
- Have known HIV infection.
- Have active hepatitis B or C infection.
- Have received a live vaccine within 30 days before starting study treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Four or more 21-day cycles
Participants receive bicalutamide daily along with sunitinib on a 2 weeks on, 1 week off schedule in repeated 21-day cycles.
Visits every 3 weeks corresponding to each treatment cycle
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
K
Kirsten Haden
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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