Study on the Safety and Effectiveness of Bicalutamide and Sunitinib for Kidney Cancer Resistant to TKIs

Sponsor: State University of New York at Buffalo

Sponsor score: 0

ClinicalTrials ID:NCT06222593

Provider View

This clinical trial is testing a combination of two drugs, bicalutamide and sunitinib, to see if they are safe and effective for patients with advanced kidney cancer that has not responded to previous treatments with receptor tyrosine kinase inhibitors (RTKIs).

Patient Parameters

Program Overview

The study aims to find out if combining bicalutamide and sunitinib can help control advanced kidney cancer that has progressed despite previous treatment with RTKIs. Patients will take sunitinib in cycles of two weeks on and one week off, with possible adjustments by the doctor. Bicalutamide will be taken daily. The study will start with 9 patients, and if there is a positive response, it will expand to 16 patients to further evaluate the treatment's effectiveness.

Description

This clinical trial is designed to evaluate the safety and effectiveness of combining bicalutamide and sunitinib in patients with advanced kidney cancer that has become resistant to previous treatments with receptor tyrosine kinase inhibitors (RTKIs). Participants will take sunitinib in a cycle of two weeks on and one week off, with the possibility of dose adjustments by their doctor. Bicalutamide will be taken daily at a dose of 50 mg. The study will initially enroll 9 patients, and if there is a positive response, it will continue to enroll up to 16 patients to further assess the treatment's potential benefits. The study uses a specific design to determine if the treatment is worth further investigation based on patient responses.

Eligibility Criteria

Inclusion Criteria

  • Willing and able to provide written consent to participate.
  • Aged 18 years or older.
  • Have measurable cancer based on specific medical criteria.
  • Have a performance status score of 0 to 2, indicating varying levels of activity.
  • Have adequate organ function as determined by medical tests.
  • Women of childbearing potential must have a negative pregnancy test 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.
  • Men without a vasectomy must agree to use contraception during the study and for 120 days after the last dose.
  • Must have available tumor tissue samples or agree to a biopsy before treatment.
  • Must have a life expectancy of at least 6 months.

Exclusion Criteria

  • Currently participating in another study or have recently participated in one within 4 weeks of starting this treatment.
  • Have an immune deficiency or are taking immune-suppressing medications within 7 days before starting the trial.
  • Have active tuberculosis (TB).
  • Have another progressing cancer that requires treatment, except for certain skin cancers or in situ cervical cancer.
  • Have active cancer spread to the brain or spinal cord.
  • Have an active infection requiring treatment.
  • Have any condition or treatment that could interfere with the study or is not in the best interest of the participant.
  • Have psychiatric or substance abuse issues that could affect participation.
  • Are pregnant, breastfeeding, or planning to conceive or father a child during the study and for 120 days after.
  • Have a history of HIV.
  • Have active Hepatitis B or C.
  • Have received a live vaccine within 30 days before starting the study treatment.

Locations

FACILITYZIPCITYSTATE
UB/ Great Lakes Cancer Care14203BuffaloNew York

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