ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer

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.
ClinicalTrials.gov Identifier: NCT01663415
Recruitment Status : Withdrawn (A business decision was made to not initiate this study.)
First Posted : August 13, 2012
Last Update Posted : September 17, 2012
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Brief Summary:
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.

Condition or disease Intervention/treatment Phase
Metastatic Castration-Resistant Prostate Cancer Drug: Enzalutamide Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Single-arm Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Study Start Date : August 2012
Estimated Primary Completion Date : October 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Enzalutamide Drug: Enzalutamide
oral
Other Name: MDV3100



Primary Outcome Measures :
  1. Radiographic progression free survival (PFS) [ Time Frame: 26 months ]
    Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2).


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 26 months ]
    Time from first dose on Day 1 to death due to any cause

  2. Time to PSA progression [ Time Frame: 26 months ]
    Time from first dose on Day 1 to first observation of PSA progression

  3. Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P) [ Time Frame: Baseline and 26 months ]
    The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients

  4. Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D) [ Time Frame: Baseline and 26 months ]
    EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents

  5. Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form) [ Time Frame: Baseline and 26 months ]
    Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use

  6. Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs) [ Time Frame: 26 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Progressive prostate cancer while on androgen deprivation therapy
  • Castrate testosterone level
  • Maintenance of surgical or medical castration for duration of study
  • Radiographically visible metastatic disease
  • Symptomatic from prostate cancer
  • Eastern Cooperative Oncology Group (ECOG) 0-2
  • Life expectancy >=6 months

Exclusion Criteria:

  • Brain metastases or leptomeningeal disease
  • Prior cytotoxic chemotherapy for prostate cancer
  • Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor
  • History of seizure or condition that may predispose to seizure
  • History of loss of consciousness or transient ischemic attack within 12 months
  • Clinically significant cardiovascular disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663415


Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Senior Medical Director Astellas Pharma Global Development

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01663415     History of Changes
Other Study ID Numbers: 9785-UC-0001
First Posted: August 13, 2012    Key Record Dates
Last Update Posted: September 17, 2012
Last Verified: September 2012

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
MDV3100
prostate
cancer
enzalutamide

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases