A Study of Continuous Oral Dosing of a Novel Antiandrogen MDV3100, in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Micro-Environment.
N/A
N/A
Male
Metastatic Progressive Castration-resistant Prostate Cancer
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 Center | Houston, Texas 77030-4096 |
