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Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Not Recruiting
Trial ID: NCT01606982
Purpose
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.
Official Title
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
Stanford Investigator(s)
Sandy Srinivas
Professor of Medicine (Oncology) and, by courtesy, of Urology
Eligibility
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)
Intervention(s):
drug: MDV3100
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Cancer Clinical Trials Office
650-498-7061