Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this treatment protocol is to provide expanded access to MDV3100 and monitor its safety in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Details

• Lead Sponsor: Astellas Pharma Global Development, Inc.
• Collaborator: Medivation, Inc.
• Treatments: Docetaxel

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

• Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or orchiectomy

• At least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel

• Progressive disease as evidenced by prostate specific antigen (PSA) rise or radiographic or clinical worsening of disease

• No known or suspected brain metastasis

• There is no comparable or satisfactory alternative therapy to treat the subject's disease

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

Exclusion Criteria:

• History of seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases, or alcoholism

• History of loss of consciousness or transient ischemic attack within the last 12 months

• Clinically significant cardiovascular disease

• Following lab values:

• Absolute neutrophil count is <1,000/µL

• Platelet count is <50,000/µL

• Hemoglobin is < 5.6 mmol/L (9 g/dL)

• Total bilirubin ≥1.5 x upper limit of normal (ULN)

• Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) ≥2.5 x ULN

• Creatinine clearance is less than 30 ml/min by the Cockcroft and Gault formula

• Subject's conditions suggests that a bone fracture or complication of a bone fracture (such as compression of the spinal cord or other nerves) is likely to occur very soon

• Subject has participated in a previous clinical study of MDV3100 for which the primary endpoint has not yet been reported (e.g., the PREVAIL trial)