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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


N/A
N/A
N/A
Open (Enrolling)
Male
Metastatic Castration-Resistant Prostate Cancer

Thank you

Trial Information

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 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)

Type of Study:

Expanded Access

Study Design:

N/A

Authority:

United States: Food and Drug Administration

Study ID:

9785-CL-0401

NCT ID:

NCT01606982

Start Date:

Completion Date:

Related Keywords:

  • Metastatic Castration-Resistant Prostate Cancer
  • MDV3100
  • prostate
  • cancer
  • Prostatic Neoplasms

Name

Location

Abington Memorial Hospital Abington, Pennsylvania  19001
Virginia Oncology Associates Newport News, Virginia  23606
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Jackson Oncology Associates, PLLC Jackson, Mississippi  39202
University of Pennsylvania Philadelphia, Pennsylvania  19104
Oregon Health & Science University Portland, Oregon  97201
Northwest Medical Specialties, PLLC Tacoma, Washington  98405
Alaska Clinical Research Center, LLC Anchorage, Alaska  99508
AccuMed Research Associates Garden City, New York  11530
Northwest Georgia Oncology Centers, P.C. Marietta, Georgia  30060
Karmanos Cancer Institute Detroit, Michigan  48201
Carolina Urologic Research Center Myrtle Beach, South Carolina  29572
Cancer Care Centers of South Texas San Antonio, Texas  78229
Stanford University Cancer Center Stanford, California  94305
Cancer Centers of North Carolina Raleigh, North Carolina  27607
Charleston Hematology Oncology Associates, PA Charleston, South Carolina  29403
Peachtree Hematology-Oncology Consultants, P.C. Atlanta, Georgia  30309
The Jones Clinic, Pc Germantown, Tennessee  38138
Southwestern Regional Medical Center Tulsa, Oklahoma  74133
Redwood Regional Medical Group, Inc. Santa Rosa, California  95403
Pinnacle Oncology Hematology Scottsdale, Arizona  85258
Illinois CancerCare, P.C. Bloomington, Illinois  61701
Georgetown Lombardi Comprehensive Cancer Center Washington, District of Columbia  20007
Ronald H. Yanagihara, MD - Gilroy, California  95020
Tower Urology / Tower Research Institute Los Angeles, California  90048
Prostate Oncology Specialist Inc. Marina Del Rey, California  90292
Ocala Oncolgy Center Ocala, Florida  34471
Investigative Clinical Research of Indiana, LLC - Indianapolis, Indiana  46260
Metairie Oncologist, LLC Metairie, Louisiana  70006
Nebraska Hemotology - Oncology PPC Lincoln, Nebraska  68506
New Hampshire Oncology Hematology PA Hooksett, New Hampshire  03106
UT Southwesern Medical Center Dallas, Texas  75390
GU Research Network Omaha, Nebraska  68130
George Washington University Medical Faculty Assoc Washington DC, District of Columbia  20037
Comprehensive Cancer Centers of NV Las Vegas, Nevada  89169
Tulsa Cancer Institute Tulsa, Oklahoma  74136