Carcinoma, Renal CellPhase 1/2NCT06222593
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
A Phase 1/2 study testing Bicalutamide in combination with Sunitinib in people with Carcinoma, Renal Cell, run by State University of New York at Buffalo at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- What is being tested?
- Bicalutamide in combination with Sunitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 1 Jul 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be willing and able to provide written informed consent for the trial.
- Be greater than or equal to 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Demonstrate adequate organ function
- 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.
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- 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
- 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.
- Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
- Subjects must have a life expectancy of at least 6 months.
Who cannot join
- 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.
- 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.
- Has active Bacillus tuberculosis (TB)
- 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.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
- Has an active infection requiring systemic therapy.
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- 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.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- 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.
- Has a known history of Human Immunodeficiency Virus (HIV)
- Has known active Hepatitis B or Hepatitis C
- Has received a live vaccine within 30 days of planned start of study therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UB/ Great Lakes Cancer Care
Buffalo, New York, 14203
About this study
Official title: 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
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.
Read the 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
- Being tested
- Bicalutamide in combination with Sunitinib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicalutamide in combination with SunitinibDrug
Also called (RS)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl sulfonyl]-2-hydroxy-2-methylpropanamide, UNII: A0Z3NAU9DP, CASODEX
Antineoplastics, Antiandrogen; CYP3A4 Inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Bicalutamide in combination with Sunitinib | Experimental | Bicalutamide 50mg once a day (QD) in combination with sunitinib 37.5mg, 25mg or 50mg QD (2 weeks ON, 1 week OFF). Four or more 21 day-long cycles. Receives: Drug: Bicalutamide in combination with Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Investigators will report the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Measured: 3 years
To assess efficacy of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Investigators will also report the number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2024
- Study start1 Oct 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies of the same condition, open and under way.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Longitudinal
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Pili, State University of New York at Buffalo
- Investigators
- Roberto Pili, MD, Principal investigator, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06222593
- Sponsor's protocol ID
- STUDY00006224
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06222593
- Acronym / sponsor ID
- STUDY00006224
- Conditions
- Carcinoma, Renal Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 24 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Longitudinal
| Arm | Type | Receives |
|---|---|---|
| Bicalutamide in combination with Sunitinib | Experimental | Drug: Bicalutamide in combination with SunitinibBicalutamide 50mg once a day (QD) in combination with sunitinib 37.5mg, 25mg or 50mg QD (2 weeks ON, 1 week OFF). Four or more 21 day-long cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Be willing and able to provide written informed consent for the trial.
- Be greater than or equal to 18 years of age on day of signing informed consent.
- Have measurable disease based on RECIST 1.1
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Demonstrate adequate organ function
Key exclusion criteria (12 listed)
- 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.
- 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.
- Has active Bacillus tuberculosis (TB)
- 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.
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bicalutamide in combination with SunitinibAlso: (RS)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl sulfonyl]-2-hydroxy-2-methylpropanamide, UNII: A0Z3NAU9DP, CASODEXAntineoplastics, Antiandrogen; CYP3A4 Inhibitor | Drug | Bicalutamide in combination with Sunitinib |
Primary outcome
To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Time frame: 3 years
Investigators will report the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
To assess efficacy of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma.
Time frame: 3 years
Investigators will also report the number of patients who achieve either partial or complete response by RECIST criteria on tumor imaging.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Roberto Pili, MD principal investigator
State University of New York at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Bicalutamide in combination with Sunitinib in people with Carcinoma, Renal Cell, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Pili, MD/PhD ((716) 878-3317, rpili@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety and tolerability of bicalutamide in combination with sunitinib in patients with RTKIs-resistant renal cell carcinoma. (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.