- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06222593
Study to Evaluate the Safety and Efficacy of Bicalutamide in Combination With Sunitinib in Patients With TKIs-resistant RCC
March 21, 2024 updated by: Roberto Pili, State University of New York at Buffalo
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
28
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Roberto Pili, MD/PhD
- Phone Number: (716) 878-3317
- Email: rpili@buffalo.edu
Study Contact Backup
- Name: Ashlee Lang, MPH
- Phone Number: 17168600267
- Email: alang@kaleidahealth.org
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bicalutamide in combination with Sunitinib
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.
|
Antineoplastics, Antiandrogen; CYP3A4 Inhibitor
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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.
|
3 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To characterize expression of AR-related micro-RNA (miR) in tumor and/or blood by polymerase chain reaction (PCR)
Time Frame: 3 years
|
Outcome measure: ratio of miR expression with respect to the gene of reference
|
3 years
|
To characterize Kallikrein-2 (KLK2) expression in blood by ELISA
Time Frame: 3 years
|
ELISA test calculates the concentration of protein as ng per ml of serum/blood.
|
3 years
|
To characterize androgen receptor (AR) expression in tumor samples immunohistochemistry (IHC)
Time Frame: 3 years
|
The outcome measure is IHC score (scale goes from 0-3, 0 being better outcome and 3 being the worst outcome) (0): negative staining
|
3 years
|
To characterize KLK2 expression in tumor samples immunohistochemistry (IHC)
Time Frame: 3 years
|
The outcome measure is IHC score (scale goes from 0-3, 0 being better outcome and 3 being the worst outcome) (0): negative staining
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Roberto Pili, MD/PhD, 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 Major Dates
Study Start (Estimated)
April 1, 2024
Primary Completion (Estimated)
July 1, 2025
Study Completion (Estimated)
July 1, 2026
Study Registration Dates
First Submitted
November 11, 2022
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 24, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2024
Last Update Submitted That Met QC Criteria
March 21, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Carcinoma, Renal Cell
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Protein Kinase Inhibitors
- Hormone Antagonists
- Androgen Antagonists
- Sunitinib
- Bicalutamide
Other Study ID Numbers
- STUDY00006224
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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