Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide

Pfizer

Status and phase: Completed; Phase 2

Conditions: Metastatic Progressive Castration-resistant Prostate Cancer

Treatments: Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01091103

C3431017 (Other Identifier)

CRPC-MDA-1

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Enzalutamide

Experimental group

Description:

Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression, unacceptable toxicity, or withdrawal.

Treatment:

Drug: Enzalutamide