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

Completed · Phase 3 · Has a placebo group

Conditions studied: Castration-Resistant Prostate Cancer

In brief

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.

Key facts

Study ID

NCT00974311

Run by

Pfizer

People needed

1199

Starts

2009-09-30

Expected to finish

2017-11-02

Last updated by the study team

2018-12-11

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Eastern Cooperative Oncology Group (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

You may not qualify if…

• Metastases in the brain or active epidural disease
• Another malignancy within the previous 5 years
• Clinically significant cardiovascular disease
• Gastrointestinal disorder affecting absorption

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Mayo Clinic Hospital — Phoenix, Arizona, United States
• Premiere Oncology of Arizona — Scottsdale, Arizona, United States
• Mayo Clinic Arizona — Scottsdale, Arizona, United States
• Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group — Beverly Hills, California, United States
• USC Westside Prostate Cancer Center — Beverly Hills, California, United States
• City of Hope — Duarte, California, United States
• Cancer Center Oncology Medical Group — La Mesa, California, United States
• LAC & USC Medical Center — Los Angeles, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA — Los Angeles, California, United States
• c/o Prostate Oncology Specialist, Inc. — Marina del Rey, California, United States
• North County Oncology Medical Clinic, Inc, — Oceanside, California, United States
• Medical Oncology Associates - SD — San Diego, California, United States
• Sharp Memorial Hospital Investigational Pharmacy — San Diego, California, United States
• Sharp Rees-Stealy — San Diego, California, United States
• UCSF Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
• City of Hope Medical Group — South Pasadena, California, United States
• Stanford Hospital and Clinics Research Pharmacy — Stanford, California, United States
• Stanford University Medical Center — Stanford, California, United States
• Research Pharmacist — Aurora, Colorado, United States
• University of Colorado Denver, Anschutz Cancer Pavilion — Aurora, Colorado, United States
• C/O: Thomas Ferencz R.Ph., BCOP — New Haven, Connecticut, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.