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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01606982
Expanded Access Status : Approved for marketing
First Posted : May 28, 2012
Last Update Posted : February 17, 2017
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Metastatic Castration-Resistant Prostate Cancer Drug: MDV3100

Detailed Description:

THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) AND HEALTH CANADA HAVE APPROVED MDV3100 (ENZALUTAMIDE) FOR SALE TO THE PUBLIC, ENROLLMENT IS CLOSED IN BOTH THE UNITED STATES AND CANADA.

The expanded access treatment protocol is being conducted while marketing approval of enzalutamide is being sought. There is no age requirement.

Subjects will complete visits on Day 1, Week 4, Week 12 and then every subsequent 12 weeks until discontinued from the study.

The study will end if enzalutamide is approved for sale to the public by the country's health authority (commercially available) or if the sponsor otherwise decides or is required to end the study. If a subject would like to receive enzalutamide after the study ends, he and the doctor will decide if he should receive a prescription for enzalutamide, with a goal of avoiding any interruption in treatment.

Study Design
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Study Type : Expanded Access
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Interventions
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Intervention Details:
  • Drug: MDV3100
    oral
    Other Names:
    • Xtandi
    • enzalutamide (USAN)
Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Criteria

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)
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT01606982    
Other Study ID Numbers: 9785-CL-0401
First Posted: May 28, 2012    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
prostate
MDV3100
cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases