NCT06222593 Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
| NCT ID | NCT06222593 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | State University of New York at Buffalo |
| Condition | Carcinoma, Renal Cell |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 28 participants in total. It began in 2024-10-01 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Be willing and able to provide written informed consent for the trial. 2. Be greater than or equal to 18 years of age on day of signing informed consent. 3. Have measurable disease based on RECIST 1.1 4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale 5. Demonstrate adequate organ function 6. Female subject of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication. 7. Subjects of childbearing potential should be willing to use 2 methods of contraception for the course of the study through 120 days after the last dose of study medication 8. Male subjects without a previous vasectomy should agree to use an adequate method of contraception (i.e. abstinence, condom with spermicidal foam/gel/film/cream) starting with the first dose of study therapy through 120 days after the last dose of study therapy. 9. Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment. 10. Subjects must have a life expectancy of at least 6 months. Exclusion Criteria: 1. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment. 2. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. 3. Has active Bacillus tuberculosis (TB) 4. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer. 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 6. Has an active infection requiring systemic therapy. 7. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator. 8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. 9. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 10. Has a known history of Human Immunodeficiency Virus (HIV) 11. Has known active Hepatitis B or Hepatitis C 12. Has received a live vaccine within 30 days of planned start of study therapy
Contact & Investigator
Roberto Pili, MD
PRINCIPAL INVESTIGATOR
State University of New York at Buffalo
Frequently Asked Questions
Who can join the NCT06222593 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Carcinoma, Renal Cell. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06222593 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06222593 currently recruiting?
Yes, NCT06222593 is actively recruiting participants. Contact the research team at rpili@buffalo.edu for enrollment information.
Where is the NCT06222593 trial being conducted?
This trial is being conducted at Buffalo, United States.
Who is sponsoring the NCT06222593 clinical trial?
NCT06222593 is sponsored by State University of New York at Buffalo. The principal investigator is Roberto Pili, MD at State University of New York at Buffalo. The trial plans to enroll 28 participants.