Treatment
This clinical trial is studying a potential treatment for men with metastatic castration resistant prostate cancer
Clinicaltrials.gov identifier:NCT03460977
Study Contact Information:
Metastatic Castration Resistant Prostate Cancer Clinical Trial
Treatment
This clinical trial is studying a potential treatment for men with metastatic castration resistant prostate cancer
Clinicaltrials.gov identifier:NCT03460977
Study Contact Information:
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 .
This Study is Open To:
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
This Study is NOT Open To:
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.
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 Contact Information:
Locations:
Arizona
City: Tucson RECRUITING
Facility: Urological Associates of Southern Arizona, P.C .
Contact Info:
No contact info provided
City: Tucson RECRUITING
Facility: Urological Associates of Southern Arizona, PC
Contact Info:
No contact info provided
Connecticut
City: Norwalk RECRUITING
Facility: Norwalk Hospital
Contact Info:
No contact info provided
Massachusetts
City: Boston RECRUITING
Facility: Brigham and Women's Hospital
Contact Info:
No contact info provided
City: Boston RECRUITING
Facility: Dana Farber Cancer Institute
Contact Info:
No contact info provided
Nebraska
City: Omaha RECRUITING
Facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists
Contact Info:
No contact info provided
Oklahoma
City: Oklahoma City RECRUITING
Facility: OU Medical Center Presbyterian Tower
Contact Info:
No contact info provided
City: Oklahoma City RECRUITING
Facility: Stephenson Cancer Center
Contact Info:
No contact info provided
South Carolina
City: Myrtle Beach RECRUITING
Facility: Carolina Urologic Research Center
Contact Info:
No contact info provided
City: Myrtle Beach RECRUITING
Facility: Parkway Surgery Center
Contact Info:
No contact info provided
Tennessee
City: Nashville RECRUITING
Facility: Tennessee Oncolgy, PLLC
Contact Info:
No contact info provided
City: Nashville RECRUITING
Facility: Tennessee Oncology, PLLC
Contact Info:
No contact info provided
City: Nashville RECRUITING
Facility: The Sarah Cannon Research Institute
Contact Info:
No contact info provided
Texas
City: Dallas RECRUITING
Facility: University of Texas Southwestern Medical Center - Simmons Cancer Center
Contact Info:
No contact info provided
City: Dallas RECRUITING
Facility: UT Southwestern Medical Center
Contact Info:
No contact info provided
City: Dallas RECRUITING
Facility: UT Southwestern University Hospital - William P. Clements, Jr
Contact Info:
No contact info provided
City: Dallas RECRUITING
Facility: UT Southwestern University Hospital - Zale Lipshy
Contact Info:
No contact info provided
Virginia
City: Fairfax RECRUITING
Facility: Virginia Cancer Specialists, PC
Contact Info:
No contact info provided
Washington
City: Seattle RECRUITING
Facility: Seattle Cancer Care Alliance
Contact Info:
No contact info provided
Other Countries
Country: China
State: Guangdong
City: Guangzhou RECRUITING
Facility: The First Affiliated Hospital of Guangzhou Medical University
Contact Info:
No contact info provided
Country: China
State: Hunan
City: Changsha RECRUITING
Facility: Hunan Cancer Hospital
Contact Info:
No contact info provided
Country: China
State: Jiangsu
City: Nanjing RECRUITING
Facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Contact Info:
No contact info provided
Country: China
State: Jiangsu
City: Nanjing RECRUITING
Facility: Zhongda Hospital Southeast University
Contact Info:
No contact info provided
Country: China
State: Sichuan
City: Cheng Du RECRUITING
Facility: West China Hospital, Sichuan University
Contact Info:
No contact info provided
Country: China
State: Zhejiang
City: Wenzhou RECRUITING
Facility: The First Affiliated Hospital of Wenzhou Medical University
Contact Info:
No contact info provided
Country: Korea, Republic of
State: Kyǒnggi-do
City: Seongnam RECRUITING
Facility: Seoul National University Bundang Hospital
Contact Info:
No contact info provided
Country: Korea, Republic of
State: Seoul-teukbyeolsi [seoul]
City: Seoul RECRUITING
Facility: Severance Hospital, Yonsei University Health System
Contact Info:
No contact info provided
Country: Korea, Republic of
State: Seoul-teukbyeolsi [seoul]
City: Seoul RECRUITING
Facility: Ewha Womans University Mokdong Hospital
Contact Info:
No contact info provided
Country: Korea, Republic of
State: Taejǒn-kwangyǒkshi
City: Daejeon RECRUITING
Facility: Chungnam national university hospital
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Hospital Quironsalud Barcelona
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Hospital Universitari Vall d'Hebron
Contact Info:
No contact info provided
Country: Spain
City: Barcelona RECRUITING
Facility: Hospital Clinic de Barcelona
Contact Info:
No contact info provided
Country: Spain
City: Castellon RECRUITING
Facility: Consorcio Hospitalario Provincial de Castellon
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario Ramon y Cajal
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: H.U. Fundación Jiménez Díaz
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario 12 De Octubre
Contact Info:
No contact info provided
Country: Spain
City: Madrid RECRUITING
Facility: Hospital Universitario HM Sanchinarro
Contact Info:
No contact info provided
Country: Spain
City: Malaga RECRUITING
Facility: Hospital Universitario Virgen de la Victoria
Contact Info:
No contact info provided
Country: Spain
City: València RECRUITING
Facility: Hospital Universitari i Politecnic La Fe
Contact Info:
No contact info provided
Country: Spain
State: Barecelona
City: L'Hospitalet de Llobregat RECRUITING
Facility: Institut Català d´Oncología (ICO)-H. Durán i Reynals
Contact Info:
No contact info provided
Country: Spain
State: Madrid
City: Pozuelo de Alarcon RECRUITING
Facility: Hospital Quironsalud Madrid
Contact Info:
No contact info provided