A Study to Test if MDV3100 is Effective and Safe in Prostate Cancer Patients Who Have Never Had Hormone Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01302041
First received: February 21, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

To determine the effect of MDV3100 on Prostate Specific Antigen (PSA), male sex hormones, bone turnover, lipid and glycemic profile (insulin and blood glucose).


Condition Intervention Phase
Prostate Cancer
Drug: MDV3100
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, Open-label, Single-arm, Efficacy and Safety Study of MDV3100 in Patients With Hormone-naïve Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • The proportion of subjects with a PSA response [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
    A PSA response is defined as a decline from baseline in PSA level of 80% or greater at week 25


Secondary Outcome Measures:
  • Safety assessed through evaluation of Adverse Events and Serious Adverse Events [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Pharmacodynamic effect of MDV3100 [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • The Pharmacokinetic assessed by analysis of Ctrough of MDV3100 and its major metabolite M2 [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • The effect of MDV3100 on PSA dynamics and kinetics [ Time Frame: Day 169 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100 Drug: MDV3100
Oral
Other Name: Enzalutamide

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed prostate cancer (all stages) for whom androgen deprivation therapy is indicated (except when indicated in a neoadjuvant/adjuvant therapy)
  • Asymptomatic from prostate cancer
  • Non-castrate level of testosterone (≥ 8 nmol/L (230 ng/dL)) at screening
  • PSA ≥ 2 ng/mL at screening

Exclusion Criteria:

Has previously or is currently receiving:

  • Hormonal therapy with intent to treat prostate cancer
  • Systemic glucocorticoids
  • Chemotherapy with the intent to treat prostate cancer
  • Opiate analgesics for pain from prostate cancer
  • Radiation therapy for treatment of the primary tumor or metastases
  • Has history of known or suspected brain or skull metastases or leptomeningeal disease
  • Has history of seizure including febrile seizure or any condition that may predispose to seizure or history of loss of consciousness or transient ischemic attack
  • Clinically significant cardiovascular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01302041

Locations
Belgium
Site 1003
Brussels, Belgium, B1090
Site 1001
Brussels, Belgium, 1200
Site 1002
Kortrijk, Belgium, 8500
Site 1005
Leuven, Belgium, 3000
Czech Republic
Site 3006
Olomouc, Czech Republic, 775 20
Site 3002
Prague 4, Czech Republic, 160 00
Denmark
Site 4004
Copenhagen, Denmark, 2100
Site 4002
Herlev, Denmark, 2730
Site 4001
Skejby, Denmark, 8200
Germany
Site 5005
Aachen, Germany, 52074
Site 5007
Bonn, Germany, 53111
Site 5003
Hannover, Germany, 30625
Sponsors and Collaborators
Astellas Pharma Inc
Medivation, Inc.
Investigators
Study Director: Use Central Contact Astellas Pharma Europe B.V.
  More Information

No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01302041     History of Changes
Other Study ID Numbers: 9785-CL-0321, 2010-021287-16
Study First Received: February 21, 2011
Last Updated: June 18, 2014
Health Authority: Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Astellas Pharma Inc:
Prostate Cancer
hormone-naïve
prostate specific antigen
bone turnover

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014