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

NCT01663415 | Withdrawn Phase 2

• 1 other identifier: 9785-UC-0001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metastatic Castration-Resistant Prostate Cancer

Keywords

MDV3100; prostate; cancer; enzalutamide

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• Overall survival

  26 months

• Time to PSA progression

  26 months

• Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P)

  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)

  Baseline and 26 months

• Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form)

  Baseline and 26 months

Study Arms (1)

Enzalutamide

EXPERIMENTAL

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

oral

Also known as: MDV3100

Enzalutamide

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Global Development, Inc.: lead
• Medivation, Inc.: collaborator

MeSH Terms

Conditions

Neoplasms

Interventions

enzalutamide

Study Officials

• Senior Medical Director

  Astellas Pharma Global Development

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2012
• First Posted: August 13, 2012
• Study Start: August 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 17, 2012

Record last verified: 2012-09