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

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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

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

Trial contacts and locations

248

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Data sourced from clinicaltrials.gov

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