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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


Phase 2
N/A
N/A
Not Enrolling
Male
Metastatic Castration-Resistant Prostate Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Radiographic progression free survival (PFS)

Outcome 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).

Outcome Time Frame:

26 months

Safety Issue:

No

Principal Investigator

Senior Medical Director

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

9785-UC-0001

NCT ID:

NCT01663415

Start Date:

August 2012

Completion Date:

October 2014

Related Keywords:

  • Metastatic Castration-Resistant Prostate Cancer
  • MDV3100
  • prostate
  • cancer
  • enzalutamide
  • Prostatic Neoplasms

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