A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases

Last updated: January 15, 2016
Sponsor: AstraZeneca
Overall Status: Completed

Phase

3

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

N/A

Clinical Study ID

NCT00554229
D4320C00014
2007-003227-20
  • Ages > 18
  • Male

Study Summary

Enthuse M1 is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in patients with hormone resistant prostate cancer and bone metastases.

  • This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve survival compared with placebo.

  • ZD4054(Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin A receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer patients with bone metastases.

  • All patients participating in this clinical trial will receive existing standard prostate cancer treatments in addition to trial therapy.

  • Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to standard prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may slow the progression of the tumour.

  • No patients will be deprived of standard prostate cancer therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients who answer TRUE to the following criteria may be eligible to participate in thistrial.

  1. Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that hasspread to the bone (bone metastases)

  2. Increasing Prostate Specific Antigen (PSA) over a one month period

  3. No pain, or mild pain from prostate cancer

  4. Currently receiving treatment with surgical or medical castration

Exclusion

Exclusion Criteria: Patients who answer TRUE to the following may NOT eligible to participate in this trial.

  1. Currently using opiates based pain killers)

  2. Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)

  3. Suffering from heart failure or had a myocardial infarction within last 6 months

  4. A history of epilepsy or seizures

Study Design

Total Participants: 896
Study Start date:
November 01, 2007
Estimated Completion Date:
August 31, 2011

Connect with a study center

  • Research Site

    Buenos Aires, Buenos Aires Province
    Argentina

    Site Not Available

  • Research Site

    Santa Fe, Santa Fe Province
    Argentina

    Site Not Available

  • Research Site

    Hornsby, New South Wales
    Australia

    Site Not Available

  • Research Site

    St Leonards, New South Wales
    Australia

    Site Not Available

  • Research Site

    Redcliffe, Queensland
    Australia

    Site Not Available

  • Research Site

    Ashford, South Australia
    Australia

    Site Not Available

  • Research Site

    Subiaco, Western Australia
    Australia

    Site Not Available

  • Research Site

    Graz,
    Austria

    Site Not Available

  • Research Site

    Wels,
    Austria

    Site Not Available

  • Research Site

    Brussels,
    Belgium

    Site Not Available

  • Research Site

    Gent,
    Belgium

    Site Not Available

  • Research Site

    Kortrijk,
    Belgium

    Site Not Available

  • Research Site

    Leuven,
    Belgium

    Site Not Available

  • Research Site

    Fortaleza, Ceara
    Brazil

    Site Not Available

  • Research Site

    Goiania, Goias
    Brazil

    Site Not Available

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    Belo Horizonte, Minas Gerais
    Brazil

    Site Not Available

  • Research Site

    Curitiba, Parana
    Brazil

    Site Not Available

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    Porto Alegre, Rio Grande do Sul
    Brazil

    Site Not Available

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    Ribeirao Preto, Sao Paulo
    Brazil

    Site Not Available

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    Santo Andre, Sao Paulo
    Brazil

    Site Not Available

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    Sao Paulo,
    Brazil

    Site Not Available

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    Calgary, Alberta
    Canada

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    Edmonton, Alberta
    Canada

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    Vancouver, British Columbia
    Canada

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    Kentville, Nova Scotia
    Canada

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    Barrie, Ontario
    Canada

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    Burlington, Ontario
    Canada

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    Hamilton, Ontario
    Canada

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    Kitchener, Ontario
    Canada

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    London, Ontario
    Canada

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    Mississauga, Ontario
    Canada

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    North York, Ontario
    Canada

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    Oakville, Ontario
    Canada

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    Ottawa, Ontario
    Canada

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    Toronto, Ontario
    Canada

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    Granby, Quebec
    Canada

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    Laval, Quebec
    Canada

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    Montreal, Quebec
    Canada

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    Point-Claire, Quebec
    Canada

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    Quebec City, Quebec
    Canada

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    Quebec,
    Canada

    Site Not Available

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    Haidian District, Beijing
    China

    Site Not Available

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    Xi Cheng District, Beijing
    China

    Site Not Available

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    Xicheng District, Beijing
    China

    Site Not Available

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    Wuhan, Hubei
    China

    Site Not Available

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    Nanjing, Jiangsu
    China

    Site Not Available

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    Pudong New Area, Shanghai
    China

    Site Not Available

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    Shanghai, Shanghai
    China

    Site Not Available

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    Xuhui District, Shanghai
    China

    Site Not Available

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    Xi'an, Shanxi
    China

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    Hangzhou, Zejiang
    China

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    Prague 4, Prague
    Czech Republic

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    Prague 6, Prague
    Czech Republic

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    Brno,
    Czech Republic

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    Olomouc,
    Czech Republic

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    Usti nad Labem,
    Czech Republic

    Site Not Available

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    Aalborg,
    Denmark

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    Aarhus,
    Denmark

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    Herlev,
    Denmark

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    Kobenhavn,
    Denmark

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    K�benhavn,
    Denmark

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    Joensuu,
    Finland

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    Kajaanintie,
    Finland

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    Tampere,
    Finland

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    Montpellier,
    France

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    Paris,
    France

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    Poitiers Cedex,
    France

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    Suresnes,
    France

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    Toulouse,
    France

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    Villejuif,
    France

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    Planegg, Muenchen
    Germany

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    Kirchheim, Teck
    Germany

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    Augsburg,
    Germany

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    Bad Gegeberg,
    Germany

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    Berlin,
    Germany

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    Emmendingen,
    Germany

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    Leipzig,
    Germany

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    Luebeck,
    Germany

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    Mannheim,
    Germany

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    Muenchen,
    Germany

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    Reutlingen,
    Germany

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    Hong Kong,
    Hong Kong

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    Shatin,
    Hong Kong

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    Tuen Mun,
    Hong Kong

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    Budapest,
    Hungary

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    Debrecen,
    Hungary

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    Miskolc,
    Hungary

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    Nyiregyhaza,
    Hungary

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    Szeged,
    Hungary

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    Rohini, Delhi
    India

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    Trivandrum, Kerala
    India

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    Bhopal, Madhya Pradesh
    India

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    Mumbai, Maharashtra
    India

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    Chandigarh, Punjab
    India

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    Ludhiana, Punjab
    India

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    Bikaner, Rajasthan
    India

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    Jaipur, Rajasthan
    India

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    Kolkota, West Bengal
    India

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    Gujarat,
    India

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    New Delhi,
    India

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    Milan,
    Italy

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    Rome,
    Italy

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    Asahi-City, Chiba
    Japan

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    Chiba-City, Chiba
    Japan

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    Narashino-city, Chiba
    Japan

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    Matsuyama-City, Ehime
    Japan

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    Fukuoka-City, Fukuoka
    Japan

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    Maebashi-City, Gunma
    Japan

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    Otake-City, Hiroshima
    Japan

    Site Not Available

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    Sapporo-City, Hokkaido
    Japan

    Site Not Available

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    Kobe-City, Hyogo
    Japan

    Site Not Available

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    Tsukuba-City, Ibaraki
    Japan

    Site Not Available

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    Kita-gun, Kagawa
    Japan

    Site Not Available

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    Sagamihara-City, Kanagawa
    Japan

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    Kyoto-City, Kyoto
    Japan

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    Sendai-City, Miyagi
    Japan

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    Oita-City, Oita
    Japan

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    Osaka-City, Osaka
    Japan

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    Osaka-Sayama-City, Osaka
    Japan

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    Suita-City, Osaka
    Japan

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  • Research Site

    Wako-City, Saitama
    Japan

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    Hamamatsu-city, Shizuoka
    Japan

    Site Not Available

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    Sunto-gun, Shizuoka
    Japan

    Site Not Available

  • Research Site

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

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    Fuchu_city, Tokyo
    Japan

    Site Not Available

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    Itabashi-Ku, Tokyo
    Japan

    Site Not Available

  • Research Site

    Meguro-ku, Tokyo
    Japan

    Site Not Available

  • Research Site

    Mitaka-City, Tokyo
    Japan

    Site Not Available

  • Research Site

    Shinjuku-ku, Tokyo
    Japan

    Site Not Available

  • Research Site

    Nagasaki,
    Japan

    Site Not Available

  • Research Site

    Heungduk-gu Cheongju, Chungbuk
    Korea, Republic of

    Site Not Available

  • Research Site

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Research Site

    Seo-gu, Pusan
    Korea, Republic of

    Site Not Available

  • Research Site

    Gangnam-gu, Seoul
    Korea, Republic of

    Site Not Available

  • Research Site

    Songpa-gu, Seoul
    Korea, Republic of

    Site Not Available

  • Research Site

    Metepec, Estado de Mexico
    Mexico

    Site Not Available

  • Research Site

    Distrito Federal Ciudad,
    Mexico

    Site Not Available

  • Research Site

    Mexico City,
    Mexico

    Site Not Available

  • Research Site

    Amsterdam,
    Netherlands

    Site Not Available

  • Research Site

    Eindhoven,
    Netherlands

    Site Not Available

  • Research Site

    Groningen,
    Netherlands

    Site Not Available

  • Research Site

    Nijmegen,
    Netherlands

    Site Not Available

  • Research Site

    Bialystok,
    Poland

    Site Not Available

  • Research Site

    Koscierzyna,
    Poland

    Site Not Available

  • Research Site

    Krakow,
    Poland

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    Rzeszow,
    Poland

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    Warszawa,
    Poland

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    Wroclaw,
    Poland

    Site Not Available

  • Research Site

    Coimbra,
    Portugal

    Site Not Available

  • Research Site

    Lisboa,
    Portugal

    Site Not Available

  • Research Site

    Porto,
    Portugal

    Site Not Available

  • Research Site

    Stary Oskol, Belgorodskaya region
    Russian Federation

    Site Not Available

  • Research Site

    Barnaul,
    Russian Federation

    Site Not Available

  • Research Site

    Izhevsk,
    Russian Federation

    Site Not Available

  • Research Site

    Kursk,
    Russian Federation

    Site Not Available

  • Research Site

    Moscow,
    Russian Federation

    Site Not Available

  • Research Site

    Sochi,
    Russian Federation

    Site Not Available

  • Research Site

    St. Petersgurg,
    Russian Federation

    Site Not Available

  • Research Site

    Voronezh,
    Russian Federation

    Site Not Available

  • Research Site

    Belgrade,
    Serbia

    Site Not Available

  • Research Site

    Nis,
    Serbia

    Site Not Available

  • Research Site

    Novi Sad,
    Serbia

    Site Not Available

  • Research Site

    Singapore,
    Singapore

    Site Not Available

  • Research Site

    Tygerberg, Cape Town
    South Africa

    Site Not Available

  • Research Site

    Bloemfontein,
    South Africa

    Site Not Available

  • Research Site

    Pietermaritzburg,
    South Africa

    Site Not Available

  • Research Site

    Port Elizabeth,
    South Africa

    Site Not Available

  • Research Site

    Goteborg,
    Sweden

    Site Not Available

  • Research Site

    Gothenburg,
    Sweden

    Site Not Available

  • Research Site

    Stockholm,
    Sweden

    Site Not Available

  • Research Site

    Basel,
    Switzerland

    Site Not Available

  • Research Site

    Bern,
    Switzerland

    Site Not Available

  • Research Site

    Locarno,
    Switzerland

    Site Not Available

  • Research Site

    Sursee,
    Switzerland

    Site Not Available

  • Research Site

    Kaohsiung,
    Taiwan

    Site Not Available

  • Research Site

    Taipei,
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan,
    Taiwan

    Site Not Available

  • Research Site

    Reading, Berkshire
    United Kingdom

    Site Not Available

  • Research Site

    Cambridge, Cambridgeshire
    United Kingdom

    Site Not Available

  • Research Site

    Maidstone, Kent
    United Kingdom

    Site Not Available

  • Research Site

    Huddersfield, Yorkshire
    United Kingdom

    Site Not Available

  • Research Site

    London,
    United Kingdom

    Site Not Available

  • Research Site

    Tucson, Arizona
    United States

    Site Not Available

  • Research Site

    Greenbrae, California
    United States

    Site Not Available

  • Research Site

    Los Angeles, California
    United States

    Site Not Available

  • Research Site

    Palm Springs, California
    United States

    Site Not Available

  • Research Site

    San Mateo, California
    United States

    Site Not Available

  • Research Site

    Norwich, Connecticut
    United States

    Site Not Available

  • Research Site

    Washington, District of Columbia
    United States

    Site Not Available

  • Research Site

    Gainsville, Florida
    United States

    Site Not Available

  • Research Site

    Port St.Lucie, Florida
    United States

    Site Not Available

  • Research Site

    Des Moines, Iowa
    United States

    Site Not Available

  • Research Site

    Canton, Ohio
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

  • Research Site

    Nashville, Tennessee
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah
    United States

    Site Not Available

  • Research Site

    Burlington, Vermont
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia
    United States

    Site Not Available

  • Research Site

    Seattle, Washington
    United States

    Site Not Available

  • Research Site

    Wheeling, West Virginia
    United States

    Site Not Available

  • Research Site

    Milwaukee, Wisconsin
    United States

    Site Not Available

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