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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 is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT01091103
First received: March 19, 2010
Last updated: August 27, 2012
Last verified: August 2012
History of Changes
  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:

U.S. FDA Resources

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
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
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: August 27, 2012
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 May 22, 2013