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

  Hide Study Locations
Locations
United States, Alaska
Alaska Clinical Research Center, LLC
Anchorage, Alaska, United States, 99508
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, California
Ronald H. Yanagihara, MD -
Gilroy, California, United States, 95020
Tower Urology / Tower Research Institute
Los Angeles, California, United States, 90048
Prostate Oncology Specialist Inc.
Marina Del Rey, California, United States, 90292
Stanford University Cancer Center
Palo Alto, California, United States, 94304
Redwood Regional Medical Group, Inc.
Santa Rosa, California, United States, 95403
United States, District of Columbia
Georgetown Lombardi Comprehensive Cancer Center
Washington DC, District of Columbia, United States, 20007
George Washington University Medical Faculty Assoc
Washington DC, District of Columbia, United States, 20037
United States, Florida
Ocala Oncolgy Center
Ocala, Florida, United States, 34471
Palm Beach Cancer Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Peachtree Hematology-Oncology Consultants, P.C.
Atlanta, Georgia, United States, 30318
Northwest Georgia Oncology Centers, P.C.
Marietta, Georgia, United States, 30060
United States, Illinois
Illinois CancerCare, P.C.
Peoria, Illinois, United States, 61615
United States, Indiana
Investigative Clinical Research of Indiana, LLC -
Indianapolis, Indiana, United States, 46260
United States, Louisiana
Metairie Oncologist, LLC
Metairie, Louisiana, United States, 70006
United States, Michigan
Karmanos Cancer Institute
Detriot, Michigan, United States, 48201
United States, Mississippi
Jackson Oncology Associates, PLLC
Jackson, Mississippi, United States, 39202
United States, Nebraska
Nebraska Hemotology - Oncology PPC
Lincoln, Nebraska, United States, 68506
GU Research Network
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of NV
Las Vegas, Nevada, United States, 89169
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, Oklahoma
Tulsa Cancer Institute
Tulsa, Oklahoma, United States, 74136
Southwestern Regional Medical Center
Tulsa, Oklahoma, United States, 74133
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
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
United States, Tennessee
The Jones Clinic, PC
Germantown, Tennessee, United States, 38138
United States, Texas
UT Southwesern Medical Center
Dallas, Texas, United States, 75390
Cancer Care Centers of South Texas
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 90048
United States, Washington
Northwest Medical Specialties, PLLC
Tacoma, Washington, United States, 98405
Canada, Alberta
Cross Cancer Institute
Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
Exdeo Clinical Reesearch, Inc
Abbotsford, British Columbia, Canada, V2S3N6
British Columbia Cancer - Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
British Columbia Cancer - Vancouver Cancer Center
Vancouver, British Columbia, Canada, V5Z 4E6
British Columbia Cancer - Vancouver Island Center
Vancouver, British Columbia, Canada, V8R 6V5
Canada, New Brunswick
Dumont Universite Hospital Center
Moncton, New Brunswick, Canada, E1C 2Z3
Canada, Nova Scotia
QEII Health Sciences Centre, Centre for Clinical Research
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Juravinski Cancer Center
Hamilton, Ontario, Canada, L8V 5C2
Centre for Aplied Uro Research at Queen's University
Kingston, Ontario, Canada, K7L 3J7
London Health Sciences Centre, London Regional Cancer Program
London, Ontario, Canada, N6A 4L6
The Ottawa Cancer Research Centre
Ottawa, Ontario, Canada, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Princess Margaret Hospital & University of Toronto
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Les Urologues Spécialisés
Montreal, Quebec, Canada, H2X 1N8
CHUM-Hôpital Notre-Dame
Montreal, Quebec, Canada, H2L 4M1
Centre De Recherche Du CHUQ-HDQ9
Quebec City, Quebec, Canada, G1R 2J6
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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 25, 2014