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



Status:Available
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:5/27/2013
Contact:Astellas Pharma Global Development
Email:clintrials.info@us.astellas.com
Phone:855-412-7865

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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


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.


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

ENROLLMENT IS OPEN IN 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.

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)
We found this trial at
36
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Dallas, Texas 75390
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4100 John R
Detroit, Michigan 48201
800-527-6266
Barbara Ann Karmanos Cancer Institute Karmanos is based in southeast Michigan, in midtown Detroit, and...
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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1309 North Flagler Drive
West Palm Beach, Florida
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1200 Old York Road
Abington, Pennsylvania 19001
(215) 481–2000
Abington Memorial Hospital Abington Memorial Hospital (AMH) is a 665-bed, regional referral center and teaching...
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Anchorage, Alaska 99508
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Bloomington, Illinois 61701
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Charleston, South Carolina 29414
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Garden City, New York 11530
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Germantown, Tennessee 38138
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Gilroy, California 95020
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Hooksett, New Hampshire 03106
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Indianapolis, IN
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Jackson, Mississippi 39202
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Las Vegas, Nevada 89169
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Lincoln, Nebraska 68506
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Los Angeles, California 90048
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Marina Del Rey, California 90292
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Metairie, Louisiana 70006
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823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Ocala, Florida 34471
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Omaha, Nebraska 68130
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Raleigh, North Carolina 27607
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100 NE Loop 410; Suite 600
San Antonio, Texas 78216
210-424-1600
Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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Santa Rosa, California 95403
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Scottsdale, Arizona 85258
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Stanford, California 94305
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Tacoma, Washington 98405
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Tulsa, Oklahoma 74133
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12697 E 51st Street South
Tulsa, Oklahoma 74146
918-505-3200
Tulsa Cancer Institute, Pllc Now under the new name of Tulsa Cancer Institute, our specialists...
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Washington, District of Columbia 20007
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Washington DC, District of Columbia 20037
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