RECRUITING

Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination with Sunitinib in Patients with TKIs-resistant RCC

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Conditions

Carcinoma, Renal Cell

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2024-10-01
Study Completion:2027-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06222593

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Be willing and able to provide written informed consent for the trial.
  2. 2. Be greater than or equal to 18 years of age on day of signing informed consent.
  3. 3. Have measurable disease based on RECIST 1.1
  4. 4. Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
  5. 5. Demonstrate adequate organ function
  6. 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. 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. 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. 9. Subjects have archival tumor tissue available or are willing to undergo a baseline biopsy prior to treatment.
  10. 10. Subjects must have a life expectancy of at least 6 months.
  1. 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. 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. 3. Has active Bacillus tuberculosis (TB)
  4. 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. 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  6. 6. Has an active infection requiring systemic therapy.
  7. 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. 8. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  9. 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. 10. Has a known history of Human Immunodeficiency Virus (HIV)
  11. 11. Has known active Hepatitis B or Hepatitis C
  12. 12. Has received a live vaccine within 30 days of planned start of study therapy

Contacts and Locations

Study Contact

Roberto Pili, MD/PhD
CONTACT
(716) 878-3317
rpili@buffalo.edu
Kirsten Haden
CONTACT
17168600267
KHaden@gppconline.com

Principal Investigator

Roberto Pili, MD
PRINCIPAL_INVESTIGATOR
State University of New York at Buffalo

Study Locations (Sites)

UB/ Great Lakes Cancer Care
Buffalo, New York, 14203
United States

Collaborators and Investigators

Sponsor: State University of New York at Buffalo

  • Roberto Pili, MD, PRINCIPAL_INVESTIGATOR, State University of New York at Buffalo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2027-07-01

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2027-07-01

Terms related to this study

Additional Relevant MeSH Terms

  • Carcinoma, Renal Cell