A study of patients with prostate cancer who have previously been treated with docetaxel-based chemotherapy, where patients receive either study drug or placebo

AFFIRM: A Multinational Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Oral MDV3100 in Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy - AFFIRM

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-013174-41-GB

Enrollment

1199

Registered

2009-09-24

Start date

2009-11-13

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy MedDRA version: 19.0 Level: PT Classification code 10060862 Term: Prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: MDV3100 Product Code: MDV3100 Pharmaceutical Form: Capsule, soft CAS Number: 915087-33-1 Other descriptive name: MDV3100

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: -Progressive prostate cancer; -One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel; -Medical or surgical castration with a testosterone level =65 years) yes F.1.3.1 Number of subjects for this age range 840

Exclusion criteria

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. Open-Label Extension Criteria for Patients Randomized to the Placebo Arm Patients randomized to the placebo arm of the blinded portion of the study must NOT meet any of the following exclusion criteria: -Known or suspected brain metastasis; -Clinically significant cardiovascular disease including

Design outcomes

Primary

Measure	Time frame
Main Objective: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.;Secondary Objective: Not Applicable.;Primary end point(s): The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups.;Timepoint(s) of evaluation of this end point: When the required number of deaths have occurred as specified in the protocol.	—

Measure

Time frame

Main Objective: • To determine the benefit of MDV3100 as compared to placebo as assessed by overall survival.;Secondary Objective: Not Applicable.;Primary end point(s): The primary efficacy outcome is a comparison of overall survival between the MDV3100-treated and the placebo groups.;Timepoint(s) of evaluation of this end point: When the required number of deaths have occurred as specified in the protocol.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable.;Timepoint(s) of evaluation of this end point: Not applicable.	—

Countries

Argentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Italy, Netherlands, Poland, South Africa, Spain, United Kingdom, United States

Contacts

Public ContactMedical Officer

Medivation, Inc.

info@medivation.com1415543-3470

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026