A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer (ENTHUSE M0)
Primary Purpose
Prostate Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ZD4054
Palcebo
Sponsored by

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
Eligibility Criteria
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
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Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
ZD4054
Arm Description
Matching Placebo
ZD4054 (Zibotentan)
Outcomes
Primary Outcome Measures
Overall Survival
Number of participants who have died at early analysis data cut off (DCO)
Progression Free Survival
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
Secondary Outcome Measures
Health Related Quality of Life
Time to Prostate-specific Antigen (PSA) Progression
Time to Symptomatic Progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00626548
Brief Title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
Acronym
ENTHUSE M0
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
early efficacy review by the Independent Data Monitoring Committee indicated it was unlikely to meet its primary efficacy endpoints
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
2577 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo
Arm Title
ZD4054
Arm Type
Experimental
Arm Description
ZD4054 (Zibotentan)
Intervention Type
Drug
Intervention Name(s)
ZD4054
Other Intervention Name(s)
Zibotentan
Intervention Description
10 mg once daily oral dose
Intervention Type
Drug
Intervention Name(s)
Palcebo
Intervention Description
Matching Plcebo oral tablet once daily
Primary Outcome Measure Information:
Title
Overall Survival
Description
Number of participants who have died at early analysis data cut off (DCO)
Time Frame
From date of randomization until date of death, assessed up to 33 months
Title
Progression Free Survival
Description
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
Time Frame
Participants were followed up for progression every 4 weeks for the first 16 weeks then every 16 weeks
Secondary Outcome Measure Information:
Title
Health Related Quality of Life
Time Frame
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Title
Time to Prostate-specific Antigen (PSA) Progression
Time Frame
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
Title
Time to Symptomatic Progression
Time Frame
Participants were followed up every 4 weeks for the first 16 weeks then every 16 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kurt Miller, Prof., M.D.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tia Higano, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
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Mannheim
Country
Germany
Facility Name
Research Site
City
Muehlacker
Country
Germany
Facility Name
Research Site
City
Muehlheim an der Ruhr
Country
Germany
Facility Name
Research Site
City
Muenchen-Planegg
Country
Germany
Facility Name
Research Site
City
Muenchen
Country
Germany
Facility Name
Research Site
City
Muenster
Country
Germany
Facility Name
Research Site
City
Reutlingen
Country
Germany
Facility Name
Research Site
City
Rostock
Country
Germany
Facility Name
Research Site
City
Tuebingen
Country
Germany
Facility Name
Research Site
City
Waltshut-Tiengen
Country
Germany
Facility Name
Research Site
City
Wuppertal
Country
Germany
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Gyor
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nyiregyhaza
Country
Hungary
Facility Name
Research Site
City
Szeged
Country
Hungary
Facility Name
Research Site
City
Szekesfehervar
Country
Hungary
Facility Name
Research Site
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Nadiad
State/Province
Gujarat
Country
India
Facility Name
Research Site
City
Kochi
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Chennai
State/Province
Tamil Nadu, India
Country
India
Facility Name
Research Site
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Research Site
City
Kolkota
State/Province
West Bengal
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Dublin 7
Country
Ireland
Facility Name
Research Site
City
Dublin 8
Country
Ireland
Facility Name
Research Site
City
Dublin
Country
Ireland
Facility Name
Research Site
City
Be'er Sheva
Country
Israel
Facility Name
Research Site
City
Be'er-Ya'akov
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Holon
Country
Israel
Facility Name
Research Site
City
Jeruslaem
Country
Israel
Facility Name
Research Site
City
Petah-Tikva
Country
Israel
Facility Name
Research Site
City
Tel-HaShomer - Ramat Gan
Country
Israel
Facility Name
Research Site
City
Ancona
Country
Italy
Facility Name
Research Site
City
Bari
Country
Italy
Facility Name
Research Site
City
Bergamo
Country
Italy
Facility Name
Research Site
City
Bologna
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Como
Country
Italy
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Messina
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Rome
Country
Italy
Facility Name
Research Site
City
Terni
Country
Italy
Facility Name
Research Site
City
Varese
Country
Italy
Facility Name
Research Site
City
Hirosaki-City
State/Province
Aomori
Country
Japan
Facility Name
Research Site
City
Chiba-City
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Narashino-city
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Matsuyama-City
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Fukuoka-City
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Maebashi-City
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Otake-City
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Sapporo-City
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Kobe-City
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Ibaraki-machi
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Mito-City
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Tsukuba-City
State/Province
Ibaraki
Country
Japan
Facility Name
Research Site
City
Kita-gun
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Sagamihara-City
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kamigyo-ku
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Kyoto-City
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Sendai-City
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Ueda-City
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Research Site
City
Oita-City
State/Province
Oita
Country
Japan
Facility Name
Research Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Osaka-City
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Osaka-Sayama-City
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Suita-City
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Wako-City
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Hamamatsu-city
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Fuchu_city
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Itabashi-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Meguro-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Minato-Ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Mitaka-City
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Kyoto
Country
Japan
Facility Name
Research Site
City
Nagasaki
Country
Japan
Facility Name
Research Site
City
Bundang-Gu, Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research Site
City
Seo-gu
State/Province
Pusan
Country
Korea, Republic of
Facility Name
Research Site
City
Gangnam-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Seodaemun-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Seongbuk-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Songpa-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Liepaja
Country
Latvia
Facility Name
Research Site
City
Riga
Country
Latvia
Facility Name
Research Site
City
Distrito Federal
State/Province
Ciudad de Mexico
Country
Mexico
Facility Name
Research Site
City
Mexico DF
State/Province
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Arnhem
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Hertogenbosch
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Rotterdam
Country
Netherlands
Facility Name
Research Site
City
Tilburg
Country
Netherlands
Facility Name
Research Site
City
Tonsberg
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Arequipa
Country
Peru
Facility Name
Research Site
City
Bellavista
Country
Peru
Facility Name
Research Site
City
Jesus Maria
Country
Peru
Facility Name
Research Site
City
Lima
Country
Peru
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Kielce
Country
Poland
Facility Name
Research Site
City
Koscierzyna
Country
Poland
Facility Name
Research Site
City
Szczecin
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Coimbra
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Timisoara
State/Province
Timis
Country
Romania
Facility Name
Research Site
City
Bucuresti
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
Country
Romania
Facility Name
Research Site
City
Omsk
State/Province
Omsk region
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
State/Province
Russia
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
State/Province
Tomsk Region
Country
Russian Federation
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Kursk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Sochi
Country
Russian Federation
Facility Name
Research Site
City
St.Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Voronezh
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Nis
Country
Serbia
Facility Name
Research Site
City
Novi Sad
Country
Serbia
Facility Name
Research Site
City
Observatory
State/Province
Cape Town
Country
South Africa
Facility Name
Research Site
City
Tygerberg
State/Province
Cape Town
Country
South Africa
Facility Name
Research Site
City
Overport
State/Province
Durban
Country
South Africa
Facility Name
Research Site
City
Parktown
State/Province
Johannesburg
Country
South Africa
Facility Name
Research Site
City
Pietermaritzburg
Country
South Africa
Facility Name
Research Site
City
Pretoria
Country
South Africa
Facility Name
Research Site
City
Elche
State/Province
Alicante
Country
Spain
Facility Name
Research Site
City
Barakaldo
State/Province
Bizkaia
Country
Spain
Facility Name
Research Site
City
Bilbao
State/Province
Vizcaya
Country
Spain
Facility Name
Research Site
City
A Corunna
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Valencia
Country
Spain
Facility Name
Research Site
City
Gothenburg
Country
Sweden
Facility Name
Research Site
City
Helsingborg
Country
Sweden
Facility Name
Research Site
City
Jonkoping
Country
Sweden
Facility Name
Research Site
City
Orebro
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
Facility Name
Research Site
City
Aarau
Country
Switzerland
Facility Name
Research Site
City
CH-4031 Basel
Country
Switzerland
Facility Name
Research Site
City
Locarno
Country
Switzerland
Facility Name
Research Site
City
Zuerich
Country
Switzerland
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
Country
Turkey
Facility Name
Research Site
City
Izmir
Country
Turkey
Facility Name
Research Site
City
Reading
State/Province
Berkshire
Country
United Kingdom
Facility Name
Research Site
City
Cottingham
State/Province
East Yorkshire
Country
United Kingdom
Facility Name
Research Site
City
Stevenage
State/Province
Hertfordshire
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Guildford
State/Province
Surrey
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
Country
United Kingdom
Facility Name
Research Site
City
Coventry
Country
United Kingdom
Facility Name
Research Site
City
Glasgow
Country
United Kingdom
Facility Name
Research Site
City
Huddersfield
Country
United Kingdom
Facility Name
Research Site
City
Liverpool
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Manchester
Country
United Kingdom
Facility Name
Research Site
City
Newcastle upon Tyne
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Non-metastatic Hormone Resistant Prostate Cancer
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