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History of Changes for Study: NCT01606982
Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy
Latest version (submitted February 15, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 24, 2012 None (earliest Version on record)
2 June 6, 2012 Study Status and Contacts/Locations
3 June 12, 2012 Contacts/Locations and Study Status
4 June 20, 2012 Contacts/Locations and Study Status
5 June 26, 2012 Contacts/Locations and Study Status
6 July 3, 2012 Study Status and Contacts/Locations
7 July 16, 2012 Contacts/Locations and Study Status
8 August 6, 2012 Study Status and Contacts/Locations
9 August 27, 2012 Eligibility and Study Status
10 October 12, 2012 Study Status, Contacts/Locations, Interventions and Study Description
11 October 18, 2012 Contacts/Locations and Study Status
12 November 7, 2012 Study Status and Contacts/Locations
13 November 27, 2012 Contacts/Locations and Study Status
14 December 18, 2012 Study Status, Contacts/Locations and Eligibility
15 January 2, 2013 Study Status and Contacts/Locations
16 February 19, 2013 Study Status and Contacts/Locations
17 April 3, 2013 Contacts/Locations and Study Status
18 April 4, 2013 Contacts/Locations and Study Status
19 July 1, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Description
20 June 5, 2015 Study Status
21 February 15, 2017 Study Status, References and Contacts/Locations
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Study NCT01606982
Submitted Date:  May 24, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: 9785-CL-0401
Brief Title: Provide Expanded Access to MDV3100 and Monitor Its Safety in Patients With Progressive 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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2012
Expanded Access Status: Available
Open or close this module Sponsor/Collaborators
Sponsor: Astellas Pharma Global Development, Inc.
Responsible Party: Sponsor
Collaborators: Medivation, Inc.
Open or close this module Oversight
Open or close this module Study Description
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.
Detailed Description:

The expanded access treatment protocol is being conducted while marketing approval of MDV3100 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 MDV3100 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 MDV3100 after the study ends, he and the doctor will decide if he should receive a prescription for MDV3100, with a goal of avoiding any interruption in treatment.

Open or close this module Conditions
Conditions: Metastatic Castration-Resistant Prostate Cancer
Keywords: MDV3100
prostate
cancer
Open or close this module Study Design
Study Type: Expanded Access
Open or close this module Interventions
Interventions: Drug: MDV3100
Other Names:
  • enzalutamide (USAN)
oral
Open or close this module Eligibility
Minimum Age:
Maximum Age:
Sex: Male
Gender Based:
Criteria:

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features
  • Ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue 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 <1,500/µL
    • Platelet count is <100,000/µL
    • Hemoglobin is < 5.6 mmol/L (9 g/dL)
    • Total bilirubin ≥1.5 x upper limit of normal (ULN)
    • Alanine aminotransferase (ALT)
    • Aspartate aminotransferase (AST) ≥2.5 x ULN
    • Creatinine value is >177 µmol/L (2 mg/dL)
    • Albumin value is <30 g/L (3.0 g/dL)
  • 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
Open or close this module Contacts/Locations
Central Contact Person: Astellas Pharma Global Development
Telephone: 855-412-7865
Email: clintrials.info@us.astellas.com
Locations: United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, New Hampshire
New Hampshire Oncology Hematology PA
Hooksett, New Hampshire, United States, 03106
United States, New York
Accumed Research Associates
Garden City, New York, United States, 11530
United States, North Carolina
Cancer Centers of North Carolina
Raleigh, North Carolina, United States, 27607
United States, South Carolina
Charleston Hematology Oncology Associates, PA
Charleston, South Carolina, United States, 29414
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Open or close this module References
Links:

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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services