Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Trial ID or NCT#
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.
A Multicenter, Single-arm, Open Label Treatment Protocol to Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
- - 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
- - 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)
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