Expanded Access to MDV3100 for Patients with Progressive Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy

Sponsor: Astellas Pharma Global Development, Inc.

Expanded Access
Approved for Marketing
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT01606982

Provider View

This program provides access to the drug MDV3100 (Enzalutamide) for patients with advanced prostate cancer that has continued to progress despite previous treatment with docetaxel-based chemotherapy. The study also monitors the safety of the drug.

Patient Parameters

Program Overview

The goal of this program is to offer MDV3100 (Enzalutamide) to patients with metastatic castration-resistant prostate cancer who have already been treated with chemotherapy that included docetaxel. The program aims to ensure the safety of the drug while it is being made available to patients before it is fully approved for sale.

Description

MDV3100, also known as Enzalutamide, has been approved by the FDA and Health Canada for public sale, and enrollment in this program is now closed in the United States and Canada.

This program was designed to provide access to Enzalutamide while awaiting full marketing approval. There is no age limit for participation.

Participants were required to attend visits on Day 1, Week 4, Week 12, and then every 12 weeks until they left the study.

The program would end if Enzalutamide became commercially available or if the sponsor decided to stop the study for any reason. If a participant wished to continue receiving Enzalutamide after the program ended, they and their doctor would discuss whether to continue with a prescription to avoid any treatment interruption.

Eligibility Criteria

Inclusion Criteria

  • Confirmed diagnosis of prostate cancer.
  • Ongoing treatment to lower male hormones, either through medication or surgery.
  • Previously received at least one chemotherapy treatment for advanced prostate cancer, including docetaxel.
  • Cancer is progressing, shown by rising PSA levels or worsening scans or symptoms.
  • No known or suspected cancer spread to the brain.
  • No other satisfactory treatment options available.
  • Able to perform daily activities with an ECOG score of 0-2.

Exclusion Criteria

  • History of seizures or conditions that could lead to seizures, such as brain injury, stroke, brain tumors, or alcoholism.
  • Recent loss of consciousness or mini-strokes within the past year.
  • Significant heart disease.
  • Blood test results showing:
    • Low white blood cell count.
    • Low platelet count.
    • Low hemoglobin levels.
    • High bilirubin levels.
    • High liver enzyme levels.
    • Poor kidney function.
  • Conditions suggesting a high risk of bone fractures or related complications.
  • Participation in a previous MDV3100 study where results are not yet available.

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