We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01606982
First Posted: May 28, 2012
Last Update Posted: February 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
May 24, 2012
May 28, 2012
February 17, 2017
 
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.

Expanded Access
Drug: MDV3100
oral
Other Names:
  • Xtandi
  • enzalutamide (USAN)
Joshua AM, Shore ND, Saad F, Chi KN, Olsson CA, Emmenegger U, Scholz M, Berry W, Mukherjee SD, Winquist E, Haas NB, Foley MA, Dmuchowski C, Perabo F, Hirmand M, Hasabou N, Rathkopf D; Enzalutamide Expanded Access Study Investigators. Safety of enzalutamide in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: expanded access in North America. Prostate. 2015 Jun;75(8):836-44. doi: 10.1002/pros.22965. Epub 2015 Feb 14.
 
Approved for marketing
Contact information is only displayed when the study is recruiting subjects
Not Provided
Canada,   United States
 
NCT01606982
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Not Provided
Astellas Pharma Inc
February 2017