Metastatic Castration-Resistant Prostate Cancer Clinical Trial
Official title:
A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.
THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) AND HEALTH CANADA HAVE APPROVED MDV3100
(ENZALUTAMIDE) FOR SALE TO THE PUBLIC, ENROLLMENT IS CLOSED IN BOTH THE UNITED STATES AND
CANADA.
The expanded access treatment protocol is being conducted while marketing approval of
enzalutamide is being sought. There is no age requirement.
Subjects will complete visits on Day 1, Week 4, Week 12 and then every subsequent 12 weeks
until discontinued from the study.
The study will end if enzalutamide is approved for sale to the public by the country's
health authority (commercially available) or if the sponsor otherwise decides or is required
to end the study. If a subject would like to receive enzalutamide after the study ends, he
and the doctor will decide if he should receive a prescription for enzalutamide, with a goal
of avoiding any interruption in treatment.
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