Back to resultsA Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
Primary Purpose
Metastatic Castration-Resistant Prostate Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Enzalutamide
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Castration-Resistant Prostate Cancer focused on measuring MDV3100, prostate, cancer, enzalutamide
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Enzalutamide
Arm Description
Outcomes
Primary Outcome Measures
Radiographic progression free survival (PFS)
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 from first dose on Day 1 to death due to any cause
Time to PSA progression
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)
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)
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)
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)
Full Information
NCT ID
NCT01663415
First Posted
August 9, 2012
Last Updated
September 14, 2012
Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Medivation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01663415
Brief Title
A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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 Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Withdrawn
Why Stopped
A business decision was made to not initiate this study.
Study Start Date
August 2012 (undefined)
Primary Completion Date
October 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Global Development, Inc.
Collaborators
Medivation, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration-Resistant Prostate Cancer
Keywords
MDV3100, prostate, cancer, enzalutamide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enzalutamide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Enzalutamide
Other Intervention Name(s)
MDV3100
Intervention Description
oral
Primary Outcome Measure Information:
Title
Radiographic progression free survival (PFS)
Description
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).
Time Frame
26 months
Secondary Outcome Measure Information:
Title
Overall survival
Description
Time from first dose on Day 1 to death due to any cause
Time Frame
26 months
Title
Time to PSA progression
Description
Time from first dose on Day 1 to first observation of PSA progression
Time Frame
26 months
Title
Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Description
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
Time Frame
Baseline and 26 months
Title
Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D)
Description
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
Time Frame
Baseline and 26 months
Title
Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)
Description
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
Time Frame
Baseline and 26 months
Title
Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs)
Time Frame
26 months
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Senior Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Safety and Efficacy of Enzalutamide in Chemotherapy-Naïve, Symptomatic Patients With Metastatic Castration-Resistant Prostate Cancer
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