AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-COntrolled Efficacy and Safety Study of Oral MDV3100 in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
18 Years
N/A
Male
Castration-Resistant Prostate Cancer
Trial Information
AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-COntrolled Efficacy and Safety Study of Oral MDV3100 in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Inclusion Criteria:
- Progressive prostate cancer
- Medical or surgical castration with testosterone less than 50 ng/dl
- One or two prior chemotherapy regimens. At least one chemotherapy regimen
must have contained docetaxel
- ECOG performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Able to swallow the study drug and comply with study requirements
- Informed consent
Exclusion Criteria:
- Metastases in the brain or active epidural disease
- Another malignancy within the previous 5 years
- Clinically significant cardiovascular disease
- GI disorder affecting absorption
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Description:
Survival is defined as time from randomization to death due to any cause. The duration of overall survival was right-censored for patients who were lost to follow-up since randomization or not known to have died at the data analysis cutoff date (this included patients who were known to have died after the data analysis cutoff date).
Outcome Time Frame:
During study period (up to 3 years)
Safety Issue:
No
Authority:
United States: Food and Drug Administration
Study ID:
CRPC2
NCT ID:
NCT00974311
Start Date:
September 2009
Completion Date:
November 2012
Related Keywords:
- Castration-Resistant Prostate Cancer
- MDV3100
- Prostate Cancer
- Castration-resistant
- Prostatic Neoplasms
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| New Britain, Connecticut 06052 | |
| Alexandria, Minnesota 56308 | |
| Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |
| Albany, Georgia 31701 | |
| Great Falls, Montana 59405 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Albany, New York 12208 | |
| Cleveland, Ohio 44195 | |
| Philadelphia, Pennsylvania 19104 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Seattle, Washington 98195 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Kansas City, Kansas 66160 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Denver, Colorado | |
| Baltimore, Maryland 21287 | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Milwaukee, Wisconsin | |
| Charleston, South Carolina | |
| Washington, District of Columbia | |
| Las Vegas, Nevada 89109 | |
| Beth Israel Deconess Medical Center | Boston, Massachusetts 02215 |
