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Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

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

Keywords

Castration-Resistant Prostate Cancer Prostate Cancer Castration-resistant Prostatic Neoplasms Docetaxel

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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 CAN'T join if...

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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center
    San Francisco, California, 94115, United States
  • Stanford Hospital and Clinics Research Pharmacy
    Stanford, California, 94305, United States
  • Stanford University Medical Center
    Stanford, California, 94305, United States
  • Tower Cancer Research Foundation, Tower Hematology Oncology Medical Group
    Beverly Hills, California, 90211-1850, United States
  • USC Westside Prostate Cancer Center
    Beverly Hills, California, 90211, United States
  • City of Hope Medical Group
    South Pasadena, California, 91030, United States
  • c/o Prostate Oncology Specialist, Inc.
    Marina Del Rey, California, 90292, United States
  • LAC & USC Medical Center
    Los Angeles, California, 90033, United States
  • USC/Norris Comprehensive Cancer Center
    Los Angeles, California, 90033, United States
  • City of Hope
    Duarte, California, 91010, United States
  • Ronald Reagan UCLA Medical Center
    Los Angeles, California, 90095-6984, United States
  • UCLA
    Los Angeles, California, 90095, United States
  • Nevada Cancer Institute, an affiliate of the UC San Diego Health System
    Las Vegas, Nevada, 89135, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89128, United States
  • Comprehensive Cancer Centers of Nevada
    Las Vegas, Nevada, 89169, United States
  • North County Oncology Medical Clinic, Inc,
    Oceanside, California, 92056, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
ID
NCT00974311
Phase
Phase 3
Study Type
Interventional
Last Updated
December 4, 2017