NCT06222593

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
13mo left

Started Oct 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress60%
Oct 2024Jul 2027

First Submitted

Initial submission to the registry

November 11, 2022

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

April 1, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

November 11, 2022

Last Update Submit

March 26, 2026

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 years

Other Outcomes (4)

  • To characterize androgen receptor (AR) expression in tumor samples immunohistochemistry (IHC)

    3 years

  • To characterize expression of AR-related micro-RNA (miR) in tumor and/or blood by polymerase chain reaction (PCR)

    3 years

  • To characterize Kallikrein-2 (KLK2) expression in blood by ELISA

    3 years

  • +1 more other outcomes

Study Arms (1)

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.

Drug: Bicalutamide in combination with Sunitinib

Interventions

Bicalutamide in combination with SunitinibDRUG

Antineoplastics, Antiandrogen; CYP3A4 Inhibitor

Also known as: (RS)-N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl sulfonyl]-2-hydroxy-2-methylpropanamide, UNII: A0Z3NAU9DP, CASODEX
Bicalutamide in combination with Sunitinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UB/ Great Lakes Cancer Care

Buffalo, New York, 14203, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

bicalutamideSunitinib

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Roberto Pili, MD

    State University of New York at Buffalo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roberto Pili, MD/PhD

CONTACT

(716) 878-3317rpili@buffalo.edu

Kirsten Haden

CONTACT

17168600267KHaden@gppconline.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Longitudinal
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Hematology/Oncology

Study Record Dates

First Submitted

November 11, 2022

First Posted

January 24, 2024

Study Start

October 1, 2024

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

April 1, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)