Trial Search Results

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

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Astellas Pharma Global Development, Inc.

Collaborator: Medivation, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: MDV3100

Phase:

N/A

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)

Ages Eligible for Study

N/A - N/A

Genders Eligible for Study

Male

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting