A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer
NCT ID: NCT00617669
Last Updated: 2012-09-10
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1494 participants
INTERVENTIONAL
2008-01-31
2011-07-31
Brief Summary
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This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can further improve survival compared with docetaxel alone.
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 compared with docetaxel.
All patients participating in this clinical trial will receive docetaxel chemotherapy, which is a commonly used chemotherapy to treat prostate cancer in addition to other existing prostate cancer therapies.
Half the patients will receive ZD4054 (Zibotentan), and half the patients will receive placebo in addition to docetaxel and other prostate cancer therapy. By participating in this trial there is a 50% chance that patients will receive an agent that may further slow the progression of the tumour.
No patients will be deprived of standard prostate cancer therapy.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo + Docetaxel
placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Docetaxel
intravenous infusion given every three weeks
Placebo
placebo oral tablet once daily
ZD4054 + Docetaxel
ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
Docetaxel
intravenous infusion given every three weeks
ZD4054
10 mg oral once daily dose
Interventions
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Docetaxel
intravenous infusion given every three weeks
ZD4054
10 mg oral once daily dose
Placebo
placebo oral tablet once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastasis)
* Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
* Currently receiving treatment with surgical or medical castration
Exclusion Criteria
* Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone). Prior targeted cancer therapies are permitted if received during a previous clinical trial.
* Suffering from heart failure or had a myocardial infarction within last 6 months
* A history of epilepsy or seizures
18 Years
MALE
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Karim Fizazi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Judd W Moul, MD, FACS
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Research Site
Greenbrae, California, United States
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San Diego, California, United States
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Norwich, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Fort Myers, Florida, United States
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Gainsville, Florida, United States
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Ocala, Florida, United States
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PORTUGALt Saint Lucie, Florida, United States
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Rockville, Maryland, United States
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Minneapolis, Minnesota, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Chapel Hill, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Canton, Ohio, United States
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Cincinnati, Ohio, United States
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Pittsburgh, Pennsylvania, United States
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Charleston, South Carolina, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Bahía Blanca, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Darlinghurst, New South Wales, Australia
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St Leonards, New South Wales, Australia
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Wollongong, New South Wales, Australia
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Redcliffe, Queensland, Australia
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Ashford, South Australia, Australia
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Footscray, Victoria, Australia
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Wodonga, Victoria, Australia
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Perth, Western Australia, Australia
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Subiaco, Western Australia, Australia
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Fortaleza, Ceara/ LA, Brazil
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Goiânia, Goias/ LA, Brazil
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Goiânia, Goiás, Brazil
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Belo Horizonte, Minas GERMANYais, Brazil
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Curitiba, Parana/ Brazil, Brazil
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Londrina, Paraná, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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PORTUGALto Alegre, Rio Grande Do Sul/ LA, Brazil
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Ribeirão Preto, Sao Paulo/ LA, Brazil
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Santo André, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Québec, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Olomouc, Czech Republic, Czechia
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Prague, Czech Republic, Czechia
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Ústí nad Labem, Czech Republic, Czechia
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Brno, Czechoslovakia Republic, Czechia
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Jablonec nad Nisou, , Czechia
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Kroměříž, , Czechia
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Prague, , Czechia
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Helsinki, Finland, Finland
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Joensuu, , Finland
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Seinäjoki, , Finland
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La Roche-sur-Yon, FRANCEnce, France
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Marseille, FRANCEnce, France
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Paris, FRANCEnce, France
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Reims, FRANCEnce, France
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Villejuif, FRANCEnce, France
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Paris, Paris, France
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Saint-Herblain, Saint Herblain, France
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Paris, , France
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Hanover, GERMANYmany, Germany
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Berlin, , Germany
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Bonn, , Germany
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Dresden, , Germany
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Emmendingen, , Germany
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Kirchheim-Teck, , Germany
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Leipzig, , Germany
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Lübeck, , Germany
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Münster, , Germany
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Tübingen, , Germany
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Wuppertal, , Germany
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Budapest, HUNGARYary, Hungary
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Győr, HUNGARYary, Hungary
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Miskolc, HUNGARYary, Hungary
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Ny Regyh Za, HUNGARYary, Hungary
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Szeged, HUNGARYary, Hungary
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Bangalore, Karnataka, India
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Trivandrum, Kerala, India
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Bhopal, Madhya Pradesh, India
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Pune, Maharashtra, India
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Bikaner, Rajasthan, India
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Jaipur, Rajasthan, India
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Vellore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Kolkota, West Bengal, India
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Delhi, , India
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New Delhi, , India
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Genoa, Italy, Italy
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Lugo (RA), Italy, Italy
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Rome, Italy, Italy
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Nijmegen, , Netherlands
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Cercado de Arequipa, Arequipa, Peru
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Cercado, Arequipa, Peru
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Callao, , Peru
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Lima, , Peru
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Lublin, POLANDand, Poland
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Swidnica, POLANDand, Poland
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Warszaa, POLANDand, Poland
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Kościerzyna, , Poland
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Wroclaw, , Poland
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Coimbra, PORTUGALtugal, Portugal
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PORTUGALto, PORTUGALtugal, Portugal
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Bucharest, , Romania
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Sibiu, , Romania
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Timișoara, , Romania
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Barnaul, RUSSIAsia, Russia
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Izhevsk, RUSSIAsia, Russia
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Kursk, RUSSIAsia, Russia
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Sochi, RUSSIAsia, Russia
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Voronezh, RUSSIAsia, Russia
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Belgrade, SERBIAbia, Serbia
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Niš, SERBIAbia, Serbia
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Panorama, Cape Town, South Africa
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TyGERberg, Cape Town, South Africa
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Overport, Durban, South Africa
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Bloemfontein, , South Africa
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Port Elizabeth, , South Africa
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Ilsandong-gu, Goyang-si, Gyeonggi-do, South Korea
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Cheongju-si, North Chungcheong, South Korea
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Nowon-gu, Seoul, South Korea
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Seodaemun-gu, Seoul, South Korea
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Songpa-gu, Seoul, South Korea
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Madrid, Spain, Spain
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Valencia, Spain, Spain
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Stockholm, Sweden, Sweden
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Uppsala, , Sweden
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Aarau, , Switzerland
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Locarno, , Switzerland
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Sursee, , Switzerland
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Kaohsiung City, TAIWANwan, Taiwan
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TAIWANpei, TAIWANwan, Taiwan
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Reading, Berkshire, United Kingdom
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Manchester, Manchester, United Kingdom
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Westgate Road, Newcastle Upon Tyne, United Kingdom
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London, , United Kingdom
Countries
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References
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Fizazi K, Higano CS, Nelson JB, Gleave M, Miller K, Morris T, Nathan FE, McIntosh S, Pemberton K, Moul JW. Phase III, randomized, placebo-controlled study of docetaxel in combination with zibotentan in patients with metastatic castration-resistant prostate cancer. J Clin Oncol. 2013 May 10;31(14):1740-7. doi: 10.1200/JCO.2012.46.4149. Epub 2013 Apr 8.
Other Identifiers
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D4320C00033
Identifier Type: -
Identifier Source: org_study_id