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 ongoing, but not recruiting participants.

First Received on September 9, 2009. Last Updated on May 9, 2012 History of Changes

Sponsor:	Medivation, Inc.
Information provided by (Responsible Party):	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 3

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

Study Start Date:	September 2009
Estimated Study Completion Date:	November 2012
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

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

Show 166 Study Locations

Sponsors and Collaborators

Medivation, Inc.

More Information

No publications provided

Responsible Party:	Medivation, Inc.
ClinicalTrials.gov Identifier:	NCT00974311 History of Changes
Other Study ID Numbers:	CRPC2
Study First Received:	September 9, 2009
Last Updated:	May 9, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:

MDV3100
Prostate Cancer
Castration-resistant

Additional relevant MeSH terms:

Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male

Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2012