Clinicaltrials.gov identifier:
NCT03460977
Treatment
This clinical trial is studying a potential treatment for men with metastatic castration resistant prostate cancer.
Study Contact Information:
Metastatic Castration Resistant Prostate Cancer Clinical Trial
About the Study
prostate cancer that no longer responds to hormone therapy is called castration resistant cancer (mCRPC). This clinical trial may be an option for you if you have been diagnosed with mCRPC that has spread or gotten worse since your last treatment. Participants will be randomly assigned to receive the current standard of care medicine, , or PF-06821497 (study medicine) orally in combination with .
What the Study Involves
The study team will meet with you to see if you are eligible to participate in this study. At your initial screening visit, the study team will ask questions about your cancer diagnosis and medical history, perform a physical exam, laboratory tests, CT/MRI scans and electrocardiogram (ECG), and possibly take a biopsy of your tumor.
The study medicine, PF-06821497, is an oral tablet taken twice a day in 21-day cycles until your cancer has gotten worse, disappeared, or you decide to leave the study. You will be able to continue taking the study medicine as long as you and your doctor believe it is a benefit to you. You will need to attend regular visits so the study team can monitor how you are responding to the medicine. These visits will include health assessments, questionnaires, blood samples, ECGs, CT/MRI scans, and optional tumor biopsies. You will also be asked to track your dose schedule in a diary.
You can change your mind at any time if you feel this study isn’t right for you.
Study Locations
This is a global clinical research study. There are 64 study sites planned in 3 countries worldwide, including:
- United States
- Russian Federation
- Spain
Key Inclusion Criteria
- Diagnosis of castration resistant cancer (mCRPC)
- Participants must have evidence of disease through imaging
- Participants should have received treatment (may have received up to 1 prior line of chemotherapy) and have not received prior , apalutamide or darolutamide and have evidence of cancer progression
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.
- Adequate organ function
Key Exclusion Criteria
- Normal heart rhythm that meets study requirements (ask your doctor)
- High blood pressure that cannot be controlled by medications (>150/90 mmHg despite optimal medical therapy).
- Known or suspected sensitivity to PF 06821497 (study drug) or any components or
- Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.