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A business decision was made to not initiate this study.
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| Name | Class |
|---|---|
| Medivation, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enzalutamide | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enzalutamide | Drug | oral |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 26 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Time from first dose on Day 1 to death due to any cause | 26 months |
| Time to PSA progression | Time from first dose on Day 1 to first observation of PSA progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Senior Medical Director | Astellas Pharma Global Development | Study Director |
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| 26 months |
| 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 | Baseline and 26 months |
| 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 | Baseline and 26 months |
| 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 | Baseline and 26 months |
| Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs) | 26 months |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C540278 | enzalutamide |
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