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A Study of Continuous Oral Dosing of a Novel Antiandrogen MDV3100, in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Micro-Environment.


Phase 2
N/A
N/A
Open (Enrolling)
Male
Metastatic Progressive Castration-resistant Prostate Cancer

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Trial Information

A Study of Continuous Oral Dosing of a Novel Antiandrogen MDV3100, in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Micro-Environment.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To explore the effect of treatment with MDV3100 on androgen signaling and expression of survival/escape pathways in the bone marrow

Outcome Description:

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.

Outcome Time Frame:

9 weeks post baseline

Safety Issue:

No

Authority:

United States: Food and Drug Administration

Study ID:

CRPC-MDA-1

NCT ID:

NCT01091103

Start Date:

February 2010

Completion Date:

Related Keywords:

  • Metastatic Progressive Castration-resistant Prostate Cancer
  • Prostatic Neoplasms

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096