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

This study has been withdrawn prior to enrollment.
(A business decision was made to not initiate this study.)
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01663415
First received: August 9, 2012
Last updated: September 14, 2012
Last verified: September 2012
History of Changes

August 9, 2012
September 14, 2012
August 2012
October 2014   (final data collection date for primary outcome measure)
Radiographic progression free survival (PFS) [ Time Frame: 26 months ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01663415 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    Time from first dose on Day 1 to death due to any cause
  • Time to PSA progression [ Time Frame: 26 months ] [ Designated as safety issue: No ]
    Time from first dose on Day 1 to first observation of PSA progression
  • 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 ] [ Designated as safety issue: No ]
    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
  • 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 ] [ Designated as safety issue: No ]
    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
  • Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form) [ Time Frame: Baseline and 26 months ] [ Designated as safety issue: No ]
    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
  • Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs) [ Time Frame: 26 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Castration-Resistant Prostate Cancer
Drug: Enzalutamide
oral
Other Name: MDV3100
Experimental: Enzalutamide
Intervention: Drug: Enzalutamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01663415
9785-UC-0001
No
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Study Director: Senior Medical Director Astellas Pharma Global Development
Astellas Pharma Inc
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP