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)

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