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.
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
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.
Single group
Bicalutamide in combination with Sunitinib
DrugAntineoplastics, Antiandrogen; CYP3A4 Inhibitor
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.
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.
To characterize androgen receptor (AR) expression in tumor samples immunohistochemistry (IHC)
The outcome measure is IHC score (scale goes from 0-3, 0 being better outcome and 3 being the worst outcome) (0): negative staining 1. : weak staining 2. : moderate staining 3. : strong staining
To characterize expression of AR-related micro-RNA (miR) in tumor and/or blood by polymerase chain reaction (PCR)
Outcome measure: ratio of miR expression with respect to the gene of reference
To characterize Kallikrein-2 (KLK2) expression in blood by ELISA
ELISA test calculates the concentration of protein as ng per ml of serum/blood.
To characterize KLK2 expression in tumor samples immunohistochemistry (IHC)
The outcome measure is IHC score (scale goes from 0-3, 0 being better outcome and 3 being the worst outcome) (0): negative staining 1. : weak staining 2. : moderate staining 3. : strong staining
Click on the lead sponsor to view all of their trials.
