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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


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Castration-Resistant Prostate Cancer

Thank you

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 HospitalBoston, 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 CenterBoston, Massachusetts  02215