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#

NCT01606982

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Sexes Eligible for Study: MALE
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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:
  2. * 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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Investigator(s)

Sandy Srinivas
Sandy Srinivas
Medical oncologist, Urologic specialist, Genitourinary specialist
Professor of Medicine (Oncology) and, by courtesy, of Urology

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Contact

Cancer Clinical Trials Office
650-498-7061

View on ClinicalTrials.gov