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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This study has been withdrawn prior to enrollment.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
  Purpose

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 Intervention Phase
Metastatic Castration-Resistant Prostate Cancer
 Drug: Enzalutamide
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide Drug: Enzalutamide
oral
Other Name: MDV3100

  Eligibility

Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663415

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

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01663415     History of Changes
Other Study ID Numbers: 9785-UC-0001
Study First Received: August 9, 2012
Last Updated: September 14, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma 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

ClinicalTrials.gov processed this record on May 23, 2013