Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy (AFFIRM)

Pfizer

Status and phase: Completed; Phase 3

Conditions: Castration-Resistant Prostate Cancer

Treatments: Drug: Placebo; Drug: Enzalutamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00974311

CRPC2

C3431010 (Other Identifier)

2009-013174-41 (EudraCT Number)

Details and patient eligibility

About

This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Enrollment: 1,199 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Progressive prostate cancer
• Medical or surgical castration with testosterone less than 50 ng/dl
• One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Adequate bone marrow, hepatic, and renal function
• Able to swallow the study drug and comply with study requirements
• Informed consent

Exclusion criteria

• Metastases in the brain or active epidural disease
• Another malignancy within the previous 5 years
• Clinically significant cardiovascular disease
• Gastrointestinal disorder affecting absorption

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,199 participants in 2 patient groups, including a placebo group

Enzalutamide

Experimental group

Description:

Formerly MDV3100

Treatment:

Drug: Enzalutamide

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo