A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)
29. august 2012 opdateret af: AstraZeneca
A Phase III, Randomised, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 (Zibotentan) 10 mg in Non-metastatic Hormone-resistant Prostate Cancer Patients
Enthuse M0 is a large phase III clinical trial studying the efficacy of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC).
This clinical trial will test if the Endothelin A Receptor Antagonist ZD4054 (Zibotentan) can improve progression-free survival and overall survival against a background of existing prostate cancer treatments.
ZD4054 (Zibotentan) is a new type of agent, which is thought to slow tumour growth and spread by blocking Endothelin receptor activity. This trial will look at the effects of ZD4054 (Zibotentan) in hormone resistant prostate cancer (HRPC) patients who have had rising PSA after surgical or medical castration but have no evidence of metastases.
All patients participating in this clinical trial will receive existing 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
2577
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Santa Fe, Argentina
- Research Site
-
-
Buenos Aires
-
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
- Research Site
-
-
Santa Fe
-
Rosario, Santa Fe, Argentina
- Research Site
-
-
-
-
-
Sydney, Australien
- Research Site
-
-
New South Wales
-
Darlinghurst, New South Wales, Australien
- Research Site
-
Hornsby, New South Wales, Australien
- Research Site
-
Westmead, New South Wales, Australien
- Research Site
-
Wollongong, New South Wales, Australien
- Research Site
-
-
Victoria
-
Wodonga, Victoria, Australien
- Research Site
-
-
Western Australia
-
Nedlands, Western Australia, Australien
- Research Site
-
-
-
-
-
(Wilrijk) Antwerpen, Belgien
- Research Site
-
Brussels, Belgien
- Research Site
-
Edegem, Belgien
- Research Site
-
Gent, Belgien
- Research Site
-
Kortrijk, Belgien
- Research Site
-
Leuven, Belgien
- Research Site
-
Liege, Belgien
- Research Site
-
-
-
-
-
Sao Paulo, Brasilien
- Research Site
-
-
Goias
-
Goiania, Goias, Brasilien
- Research Site
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasilien
- Research Site
-
-
PR
-
Londrina, PR, Brasilien
- Research Site
-
-
Parana
-
Curitiba, Parana, Brasilien
- Research Site
-
-
RJ
-
Rio de Janeiro, RJ, Brasilien
- Research Site
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien
- Research Site
-
-
Sao Paulo
-
Santo Andre, Sao Paulo, Brasilien
- Research Site
-
-
-
-
Alberta
-
Calgary, Alberta, Canada
- Research Site
-
Edmonton, Alberta, Canada
- Research Site
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Research Site
-
Victoria, British Columbia, Canada
- Research Site
-
-
Manitoba
-
Winnipeg, Manitoba, Canada
- Research Site
-
-
Ontario
-
Burlington, Ontario, Canada
- Research Site
-
Hamilton, Ontario, Canada
- Research Site
-
Kingston, Ontario, Canada
- Research Site
-
Kitchener, Ontario, Canada
- Research Site
-
London, Ontario, Canada
- Research Site
-
North York, Ontario, Canada
- Research Site
-
Oakville, Ontario, Canada
- Research Site
-
Toronto, Ontario, Canada
- Research Site
-
-
Quebec
-
Greenfeild Park, Quebec, Canada
- Research Site
-
Montreal, Quebec, Canada
- Research Site
-
Point-Claire, Quebec, Canada
- Research Site
-
Quebec City, Quebec, Canada
- Research Site
-
Sherbrooke, Quebec, Canada
- Research Site
-
-
-
-
-
La Serena, Chile
- Research Site
-
Santiago, Chile
- Research Site
-
Temuco, Chile
- Research Site
-
Vina del Mar, Chile
- Research Site
-
-
-
-
-
Bogota, Colombia
- Research Site
-
Medellin, Colombia
- Research Site
-
-
-
-
-
Aalborg, Danmark
- Research Site
-
Frederiksberg, Danmark
- Research Site
-
Herlev, Danmark
- Research Site
-
Holstebro, Danmark
- Research Site
-
Kobenhavn, Danmark
- Research Site
-
Odense, Danmark
- Research Site
-
Roskilde, Danmark
- Research Site
-
-
-
-
-
Barnaul, Den Russiske Føderation
- Research Site
-
Kursk, Den Russiske Føderation
- Research Site
-
Moscow, Den Russiske Føderation
- Research Site
-
Sochi, Den Russiske Føderation
- Research Site
-
St.Petersburg, Den Russiske Føderation
- Research Site
-
Voronezh, Den Russiske Føderation
- Research Site
-
-
Omsk region
-
Omsk, Omsk region, Den Russiske Føderation
- Research Site
-
-
Russia
-
Izhevsk, Russia, Den Russiske Føderation
- Research Site
-
-
Tomsk Region
-
Tomsk, Tomsk Region, Den Russiske Føderation
- Research Site
-
-
-
-
-
Cambridge, Det Forenede Kongerige
- Research Site
-
Coventry, Det Forenede Kongerige
- Research Site
-
Glasgow, Det Forenede Kongerige
- Research Site
-
Huddersfield, Det Forenede Kongerige
- Research Site
-
Liverpool, Det Forenede Kongerige
- Research Site
-
London, Det Forenede Kongerige
- Research Site
-
Manchester, Det Forenede Kongerige
- Research Site
-
Newcastle upon Tyne, Det Forenede Kongerige
- Research Site
-
-
Berkshire
-
Reading, Berkshire, Det Forenede Kongerige
- Research Site
-
-
East Yorkshire
-
Cottingham, East Yorkshire, Det Forenede Kongerige
- Research Site
-
-
Hertfordshire
-
Stevenage, Hertfordshire, Det Forenede Kongerige
- Research Site
-
-
Kent
-
Maidstone, Kent, Det Forenede Kongerige
- Research Site
-
-
Surrey
-
Guildford, Surrey, Det Forenede Kongerige
- Research Site
-
-
-
-
-
Helsinki, Finland
- Research Site
-
Joensuu, Finland
- Research Site
-
Oulu, Finland
- Research Site
-
Seinajoki, Finland
- Research Site
-
Tampere, Finland
- Research Site
-
-
-
-
Arizona
-
Tucson, Arizona, Forenede Stater
- Research Site
-
-
California
-
Greenbrae, California, Forenede Stater
- Research Site
-
Los Angeles, California, Forenede Stater
- Research Site
-
San Diego, California, Forenede Stater
- Research Site
-
San Francisco, California, Forenede Stater
- Research Site
-
-
Colorado
-
Denver, Colorado, Forenede Stater
- Research Site
-
-
Connecticut
-
Norwich, Connecticut, Forenede Stater
- Research Site
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater
- Research Site
-
-
Florida
-
Boca Raton, Florida, Forenede Stater
- Research Site
-
Miami, Florida, Forenede Stater
- Research Site
-
Ocala, Florida, Forenede Stater
- Research Site
-
Port St. Lucie, Florida, Forenede Stater
- Research Site
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater
- Research Site
-
Macon, Georgia, Forenede Stater
- Research Site
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater
- Research Site
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater
- Research Site
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater
- Research Site
-
Rockville, Maryland, Forenede Stater
- Research Site
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater
- Research Site
-
-
Nebraska
-
Lincoln, Nebraska, Forenede Stater
- Research Site
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater
- Research Site
-
-
New York
-
Brooklyn, New York, Forenede Stater
- Research Site
-
-
North Carolina
-
Chapel Hill, North Carolina, Forenede Stater
- Research Site
-
-
North Dakota
-
Bismarck, North Dakota, Forenede Stater
- Research Site
-
-
Ohio
-
Canton, Ohio, Forenede Stater
- Research Site
-
Cincinnati, Ohio, Forenede Stater
- Research Site
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forenede Stater
- Research Site
-
Pittsburgh, Pennsylvania, Forenede Stater
- Research Site
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater
- Research Site
-
Mystle Beach, South Carolina, Forenede Stater
- Research Site
-
Raleigh, South Carolina, Forenede Stater
- Research Site
-
-
Tennessee
-
Memphis, Tennessee, Forenede Stater
- Research Site
-
Nashville, Tennessee, Forenede Stater
- Research Site
-
-
Texas
-
San Antonio, Texas, Forenede Stater
- Research Site
-
-
Vermont
-
Burlington, Vermont, Forenede Stater
- Research Site
-
-
Washington
-
Seattle, Washington, Forenede Stater
- Research Site
-
Wenatchee, Washington, Forenede Stater
- Research Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater
- Research Site
-
-
-
-
-
Caen cedex, Frankrig
- Research Site
-
Creteil, Frankrig
- Research Site
-
Lille, Frankrig
- Research Site
-
Lyon, Frankrig
- Research Site
-
Lyon cedex 03, Frankrig
- Research Site
-
Marseille, Frankrig
- Research Site
-
Montpellier, Frankrig
- Research Site
-
Orleans Cedex, Frankrig
- Research Site
-
Paris, Frankrig
- Research Site
-
Pierre Benite cedex, Frankrig
- Research Site
-
Poitiers Cedex, Frankrig
- Research Site
-
Reims, Frankrig
- Research Site
-
Reims cedex, Frankrig
- Research Site
-
Rennes cedex 9, Frankrig
- Research Site
-
Rouen, Frankrig
- Research Site
-
Suresnes, Frankrig
- Research Site
-
Toulouse, Frankrig
- Research Site
-
Vandoeuvre-les-Nancy cedex, Frankrig
- Research Site
-
Villejuif, Frankrig
- Research Site
-
-
-
-
-
Amsterdam, Holland
- Research Site
-
Arnhem, Holland
- Research Site
-
Eindhoven, Holland
- Research Site
-
Hertogenbosch, Holland
- Research Site
-
Nijmegen, Holland
- Research Site
-
Rotterdam, Holland
- Research Site
-
Tilburg, Holland
- Research Site
-
-
-
-
-
New Delhi, Indien
- Research Site
-
-
Gujarat
-
Ahmedabad, Gujarat, Indien
- Research Site
-
Nadiad, Gujarat, Indien
- Research Site
-
-
Kerala
-
Kochi, Kerala, Indien
- Research Site
-
-
Maharashtra
-
Pune, Maharashtra, Indien
- Research Site
-
-
Tamil Nadu, India
-
Chennai, Tamil Nadu, India, Indien
- Research Site
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, Indien
- Research Site
-
-
West Bengal
-
Kolkota, West Bengal, Indien
- Research Site
-
-
-
-
-
Dublin, Irland
- Research Site
-
Dublin 7, Irland
- Research Site
-
Dublin 8, Irland
- Research Site
-
-
-
-
-
Be'er Sheva, Israel
- Research Site
-
Be'er-Ya'akov, Israel
- Research Site
-
Haifa, Israel
- Research Site
-
Holon, Israel
- Research Site
-
Jeruslaem, Israel
- Research Site
-
Petah-Tikva, Israel
- Research Site
-
Tel-HaShomer - Ramat Gan, Israel
- Research Site
-
-
-
-
-
Ancona, Italien
- Research Site
-
Bari, Italien
- Research Site
-
Bergamo, Italien
- Research Site
-
Bologna, Italien
- Research Site
-
Catania, Italien
- Research Site
-
Como, Italien
- Research Site
-
Firenze, Italien
- Research Site
-
Genova, Italien
- Research Site
-
Messina, Italien
- Research Site
-
Milano, Italien
- Research Site
-
Pisa, Italien
- Research Site
-
Rome, Italien
- Research Site
-
Terni, Italien
- Research Site
-
Varese, Italien
- Research Site
-
-
-
-
-
Kyoto, Japan
- Research Site
-
Nagasaki, Japan
- Research Site
-
-
Aomori
-
Hirosaki-City, Aomori, Japan
- Research Site
-
-
Chiba
-
Chiba-City, Chiba, Japan
- Research Site
-
Narashino-city, Chiba, Japan
- Research Site
-
-
Ehime
-
Matsuyama-City, Ehime, Japan
- Research Site
-
-
Fukuoka
-
Fukuoka-City, Fukuoka, Japan
- Research Site
-
-
Gunma
-
Maebashi-City, Gunma, Japan
- Research Site
-
-
Hiroshima
-
Otake-City, Hiroshima, Japan
- Research Site
-
-
Hokkaido
-
Sapporo-City, Hokkaido, Japan
- Research Site
-
-
Hyogo
-
Kobe-City, Hyogo, Japan
- Research Site
-
-
Ibaraki
-
Ibaraki-machi, Ibaraki, Japan
- Research Site
-
Mito-City, Ibaraki, Japan
- Research Site
-
Tsukuba-City, Ibaraki, Japan
- Research Site
-
-
Kagawa
-
Kita-gun, Kagawa, Japan
- Research Site
-
-
Kanagawa
-
Sagamihara-City, Kanagawa, Japan
- Research Site
-
-
Kyoto
-
Kamigyo-ku, Kyoto, Japan
- Research Site
-
Kyoto-City, Kyoto, Japan
- Research Site
-
-
Miyagi
-
Sendai-City, Miyagi, Japan
- Research Site
-
-
Nagano
-
Ueda-City, Nagano, Japan
- Research Site
-
-
Nara
-
Kashihara, Nara, Japan
- Research Site
-
-
Oita
-
Oita-City, Oita, Japan
- Research Site
-
-
Okayama
-
Kurashiki, Okayama, Japan
- Research Site
-
-
Osaka
-
Osaka-City, Osaka, Japan
- Research Site
-
Osaka-Sayama-City, Osaka, Japan
- Research Site
-
Suita-City, Osaka, Japan
- Research Site
-
-
Saitama
-
Wako-City, Saitama, Japan
- Research Site
-
-
Shizuoka
-
Hamamatsu-city, Shizuoka, Japan
- Research Site
-
Sunto-gun, Shizuoka, Japan
- Research Site
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japan
- Research Site
-
Fuchu_city, Tokyo, Japan
- Research Site
-
Itabashi-Ku, Tokyo, Japan
- Research Site
-
Meguro-ku, Tokyo, Japan
- Research Site
-
Minato-Ku, Tokyo, Japan
- Research Site
-
Mitaka-City, Tokyo, Japan
- Research Site
-
Shinjuku-ku, Tokyo, Japan
- Research Site
-
-
-
-
-
Ankara, Kalkun
- Research Site
-
Istanbul, Kalkun
- Research Site
-
Izmir, Kalkun
- Research Site
-
-
-
-
-
Beijing, Kina
- Research Site
-
Chongqing, Kina
- Research Site
-
Guangzhou City, Kina
- Research Site
-
Hubei, Kina
- Research Site
-
Jiangsu, Kina
- Research Site
-
Shanghai, Kina
- Research Site
-
Shanxi, Kina
- Research Site
-
Tianjin, Kina
- Research Site
-
Zejiang, Kina
- Research Site
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina
- Research Site
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- Research Site
-
-
-
-
Gyeonggi-do
-
Bundang-Gu, Seongnam-si, Gyeonggi-do, Korea, Republikken
- Research Site
-
-
Pusan
-
Seo-gu, Pusan, Korea, Republikken
- Research Site
-
-
Seoul
-
Gangnam-gu, Seoul, Korea, Republikken
- Research Site
-
Seodaemun-gu, Seoul, Korea, Republikken
- Research Site
-
Seongbuk-gu, Seoul, Korea, Republikken
- Research Site
-
Songpa-gu, Seoul, Korea, Republikken
- Research Site
-
-
-
-
-
Liepaja, Letland
- Research Site
-
Riga, Letland
- Research Site
-
-
-
-
Ciudad de Mexico
-
Distrito Federal, Ciudad de Mexico, Mexico
- Research Site
-
-
Distrito Federal
-
Mexico DF, Distrito Federal, Mexico
- Research Site
-
-
-
-
-
Tonsberg, Norge
- Research Site
-
Trondheim, Norge
- Research Site
-
-
-
-
-
Arequipa, Peru
- Research Site
-
Bellavista, Peru
- Research Site
-
Jesus Maria, Peru
- Research Site
-
Lima, Peru
- Research Site
-
-
-
-
-
Gdynia, Polen
- Research Site
-
Kielce, Polen
- Research Site
-
Koscierzyna, Polen
- Research Site
-
Szczecin, Polen
- Research Site
-
Warszawa, Polen
- Research Site
-
Wroclaw, Polen
- Research Site
-
-
-
-
-
Coimbra, Portugal
- Research Site
-
Porto, Portugal
- Research Site
-
-
-
-
-
Bucuresti, Rumænien
- Research Site
-
Cluj-Napoca, Rumænien
- Research Site
-
-
Timis
-
Timisoara, Timis, Rumænien
- Research Site
-
-
-
-
-
Aarau, Schweiz
- Research Site
-
CH-4031 Basel, Schweiz
- Research Site
-
Locarno, Schweiz
- Research Site
-
Zuerich, Schweiz
- Research Site
-
-
-
-
-
Belgrade, Serbien
- Research Site
-
Nis, Serbien
- Research Site
-
Novi Sad, Serbien
- Research Site
-
-
-
-
-
A Corunna, Spanien
- Research Site
-
Barcelona, Spanien
- Research Site
-
Madrid, Spanien
- Research Site
-
Sevilla, Spanien
- Research Site
-
Valencia, Spanien
- Research Site
-
-
Alicante
-
Elche, Alicante, Spanien
- Research Site
-
-
Bizkaia
-
Barakaldo, Bizkaia, Spanien
- Research Site
-
-
Vizcaya
-
Bilbao, Vizcaya, Spanien
- Research Site
-
-
-
-
-
Gothenburg, Sverige
- Research Site
-
Helsingborg, Sverige
- Research Site
-
Jonkoping, Sverige
- Research Site
-
Orebro, Sverige
- Research Site
-
Stockholm, Sverige
- Research Site
-
Uppsala, Sverige
- Research Site
-
-
-
-
-
Pietermaritzburg, Sydafrika
- Research Site
-
Pretoria, Sydafrika
- Research Site
-
-
Cape Town
-
Observatory, Cape Town, Sydafrika
- Research Site
-
Tygerberg, Cape Town, Sydafrika
- Research Site
-
-
Durban
-
Overport, Durban, Sydafrika
- Research Site
-
-
Johannesburg
-
Parktown, Johannesburg, Sydafrika
- Research Site
-
-
-
-
-
Taipei, Taiwan
- Research Site
-
-
-
-
-
Brno, Tjekkiet
- Research Site
-
Hradec Kralove, Tjekkiet
- Research Site
-
Jablonec nad Nisou, Tjekkiet
- Research Site
-
Kromeriz, Tjekkiet
- Research Site
-
Olomouc, Tjekkiet
- Research Site
-
Prague 2, Tjekkiet
- Research Site
-
Prague 4, Tjekkiet
- Research Site
-
Prague 6, Tjekkiet
- Research Site
-
Praha, Tjekkiet
- Research Site
-
Usti nad Labem, Tjekkiet
- Research Site
-
-
-
-
-
Augsburg, Tyskland
- Research Site
-
Bad Ems, Tyskland
- Research Site
-
Berlin, Tyskland
- Research Site
-
Bonn, Tyskland
- Research Site
-
Borken, Tyskland
- Research Site
-
Chemnitz, Tyskland
- Research Site
-
Emmendingen, Tyskland
- Research Site
-
Fuerth, Tyskland
- Research Site
-
Gelsenkirchen-Buer, Tyskland
- Research Site
-
Germering, Tyskland
- Research Site
-
Goettingen, Tyskland
- Research Site
-
Holzminden, Tyskland
- Research Site
-
Kirchheim/Teck, Tyskland
- Research Site
-
Leipzig, Tyskland
- Research Site
-
Lubeck, Tyskland
- Research Site
-
Mannheim, Tyskland
- Research Site
-
Muehlacker, Tyskland
- Research Site
-
Muehlheim an der Ruhr, Tyskland
- Research Site
-
Muenchen, Tyskland
- Research Site
-
Muenchen-Planegg, Tyskland
- Research Site
-
Muenster, Tyskland
- Research Site
-
Reutlingen, Tyskland
- Research Site
-
Rostock, Tyskland
- Research Site
-
Tuebingen, Tyskland
- Research Site
-
Waltshut-Tiengen, Tyskland
- Research Site
-
Wuppertal, Tyskland
- Research Site
-
-
-
-
-
Budapest, Ungarn
- Research Site
-
Debrecen, Ungarn
- Research Site
-
Gyor, Ungarn
- Research Site
-
Miskolc, Ungarn
- Research Site
-
Nyiregyhaza, Ungarn
- Research Site
-
Szeged, Ungarn
- Research Site
-
Szekesfehervar, Ungarn
- Research Site
-
-
-
-
-
Graz, Østrig
- Research Site
-
Innsbruck, Østrig
- Research Site
-
Wels, Østrig
- Research Site
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Beskrivelse
Inclusion Criteria:
Patients who answer TRUE to the following criteria may be eligible to participate in this study.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has NOT spread to the other parts of the body (metastases). Patients with lymph node involvement may be eligible if specified criteria is met.
- Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
- Currently receiving treatment with surgical or medical castration
Exclusion Criteria:
Patients who answer TRUE to the following may NOT be eligible to participate in this study.
- Currently using opiate based pain killers for cancer related pain
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
Matchende placebo
|
Matching Plcebo oral tablet once daily
|
|
Eksperimentel: ZD4054
ZD4054 (Zibotentan)
|
10 mg once daily oral dose
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Overall Survival
Tidsramme: From date of randomization until date of death, assessed up to 33 months
|
Number of participants who have died at early analysis data cut off (DCO)
|
From date of randomization until date of death, assessed up to 33 months
|
|
Progression Free Survival
Tidsramme: Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
|
Number of participants who have a progression event at the early analysis DCO, where progression is defined, using RECIST, as a measurable increase in the smallest dimension of any target or non-target lesion, or the appearance of new lesions, since baseline
|
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Health Related Quality of Life
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
|
Time to Prostate-specific Antigen (PSA) Progression
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
|
Time to Symptomatic Progression
Tidsramme: Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Kurt Miller, Prof., M.D., Charite University, Berlin, Germany
- Ledende efterforsker: Tia Higano, MD, University of Washington
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. januar 2008
Primær færdiggørelse (Faktiske)
1. januar 2011
Studieafslutning (Faktiske)
1. maj 2011
Datoer for studieregistrering
Først indsendt
24. januar 2008
Først indsendt, der opfyldte QC-kriterier
21. februar 2008
Først opslået (Skøn)
29. februar 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
3. september 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. august 2012
Sidst verificeret
1. april 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D4320C00015
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Palcebo
-
Ain Shams UniversityRekruttering
-
MindRank AI LtdRekruttering
-
Maastricht University Medical CenterTop Institute Food and NutritionAfsluttetFedme | Type 2 diabetesHolland
-
Chinese PLA General HospitalUkendtVenstre ventrikulær dysfunktion | Kronisk myokardieiskæmi | Gammelt myokardieinfarktKina
-
Institute of Liver and Biliary Sciences, IndiaAfsluttet
-
University Hospital, GrenobleAGIR à DomAfsluttet
-
Jiangsu Hansoh Pharmaceutical Co., Ltd.Afsluttet
-
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate...Afsluttet
-
Mohsen PouraziziIkke rekrutterer endnuØjensmerter | Okulær overfladesygdom | Øjenbetændelse | Okulær overfladesymptomIran, Islamisk Republik
-
Fudan UniversityAfsluttetST Elevation Myokardieinfarkt | Perkutan koronar interventionKina