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., February 2010

First Received: September 9, 2009 Last Updated: February 3, 2010 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

Show 51 Study Locations

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:	February 3, 2010
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 February 08, 2010