Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy - Full Text View

Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

This study is currently recruiting participants.

Verified by Medivation, Inc., November 2009

First Received: September 9, 2009 Last Updated: November 18, 2009 History of Changes

Sponsor:	Medivation, Inc.
Information provided by:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00974311

Purpose

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Condition	Intervention	Phase
Castration-Resistant Prostate Cancer	Drug: MDV3100 Drug: Placebo	Phase III

Study Type:	Interventional
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Docetaxel

U.S. FDA Resources

Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:

Overall survival

Arms	Assigned Interventions
MDV3100: Experimental	Drug: MDV3100 MDV3100, 160 mg orally per day
Placebo: Placebo Comparator	Drug: Placebo

Eligibility

Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00974311

Contacts

Contact: Mohammad Hirmand, MD

415-543-3470

Locations

United States, Arizona
	Recruiting
Scottsdale, Arizona, United States, 85258
United States, California
	Recruiting
Marina Del Rey, California, United States, 90292
	Recruiting
Beverley Hills, California, United States, 90211
	Recruiting
Los Angeles, California, United States, 90024
United States, Connecticut
	Recruiting
Stamford, Connecticut, United States, 06902
United States, Georgia
	Recruiting
Atlanta, Georgia, United States, 30309
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60637
United States, Nevada
	Recruiting
Las Vegas, Nevada, United States, 89169
	Recruiting
Las Vegas, Nevada, United States, 89135
United States, New Mexico
	Recruiting
Albuquerque, New Mexico, United States, 87109
United States, New York
	Recruiting
New York, New York, United States, 10065
United States, North Carolina
	Recruiting
Raleigh, North Carolina, United States, 27607
United States, Pennsylvania
	Recruiting
Philadelphia, Pennsylvania, United States, 19111
United States, South Carolina
	Recruiting
Myrtle Beach, South Carolina, United States, 29572
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37203
	Recruiting
Chattanooga, Tennessee, United States, 37404
United States, Virginia
	Recruiting
Norfolk, Virginia, United States, 23502
	Recruiting
Richmond, Virginia, United States, 23230
Australia, Queensland
	Recruiting
South Brisbane, Queensland, Australia, 4101
Belgium
	Recruiting
Brussels, Belgium, B-1070

Sponsors and Collaborators

Medivation, Inc.

More Information

No publications provided

Responsible Party:	Medivation, Inc. ( Mohammad Hirmand, MD / Vice President, Clinical Development )
Study ID Numbers:	CRPC2
Study First Received:	September 9, 2009
Last Updated:	November 18, 2009
ClinicalTrials.gov Identifier:	NCT00974311 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:

MDV3100
Prostate Cancer
Castration-resistant

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Prostatic Diseases
Genital Neoplasms, Male

Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

ClinicalTrials.gov processed this record on November 20, 2009