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

This treatment has been approved for sale to the public.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier:
NCT01606982
First received: May 24, 2012
Last updated: July 1, 2013
Last verified: July 2013
  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.


Condition Intervention
Metastatic Castration-Resistant Prostate Cancer
Drug: MDV3100

Study Type: Expanded Access     What is 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 NLM:


Further study details as provided by Astellas Pharma Inc:

Intervention Details:
    Drug: MDV3100
    oral
    Other Names:
    • enzalutamide (USAN)
    • Xtandi
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.

  Eligibility

Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01606982

  Show 52 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
ClinicalTrials.gov Identifier: NCT01606982     History of Changes
Other Study ID Numbers: 9785-CL-0401
Study First Received: May 24, 2012
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
MDV3100
prostate
cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014