Determine the Effect of MDV3100 on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of MDV3100 to Identify Potential Predictors of Response or Resistance to Therapy

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01091103
First received: March 19, 2010
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

This study is being conducted to determine the effect of MDV3100 on the androgen signaling pathway in correlation with the anti-tumor effects of MDV3100 to identify potential predictors of response or resistance to therapy.


Condition Intervention Phase
Metastatic Progressive Castration-resistant Prostate Cancer
Drug: MDV3100
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Study of Continuous Oral Dosing of a Novel Antiandrogen MDV3100, in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Micro-Environment.

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • To explore the effect of treatment with MDV3100 on androgen signaling and expression of survival/escape pathways in the bone marrow [ Time Frame: 9 weeks post baseline ] [ Designated as safety issue: No ]
    To explore the effect of treatment with MDV3100 on androgen signaling and expression of survival/escape pathways in the bone marrow of patients with castration-resistant metastatic prostate cancer in correlation with measures of antitumor activity to identify predictors of response or resistance to therapy.


Secondary Outcome Measures:
  • To explore the antitumor activity of treatment with MDV3100. [ Time Frame: 9 weeks post baseline ] [ Designated as safety issue: No ]
    To explore the antitumor activity of treatment with MDV3100 as assessed by serum prostate-specific antigen (PSA) levels, imaging of soft tissue and bone metastases, and markers of bone metabolism;


Enrollment: 60
Study Start Date: February 2010
Study Completion Date: August 2013
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MDV3100
MDV3100 160 mg orally daily
Drug: MDV3100
MDV3100, 160 mg orally per day

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Confirmed prostate cancer
  • Presence of metastatic disease to the bone
  • Ongoing androgen deprivation therapy

Exclusion Criteria:

  • Severe concurrent disease
  • Metastases in the brain
  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: NCT01091103

Locations
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77303
Sponsors and Collaborators
Medivation, Inc.
Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT01091103     History of Changes
Other Study ID Numbers: CRPC-MDA-1
Study First Received: March 19, 2010
Last Updated: January 30, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on September 16, 2014