Prostate CancerPhase 3ENTHUSE M1NCT00554229
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
A Phase 3 study testing ZD4054 in people with Prostate Cancer, run by AstraZeneca at 197 sites in 31 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- ZD4054
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 896 participants
- Where
- 197 sitesin 31 countries
- Study dates
- Nov 2007to Aug 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
- Increasing Prostate Specific Antigen (PSA) over a one month period
- No pain, or mild pain from prostate cancer
- Currently receiving treatment with surgical or medical castration
Who cannot join
- Patients who answer TRUE to the following may NOT eligible to participate in this trial.
- Currently using opiates based pain killers)
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Trial locations and contacts
197 sites in 31 countries.
197 sites in 31 countries
Japan28 sites
Research Site
Asahi, Chiba
Research Site
Bunkyo-ku, Tokyo
Research Site
Chiba, Chiba
Research Site
Fuchu_city, Tokyo
Research Site
Fukuoka, Fukuoka
Research Site
Hamamatsu, Shizuoka
Research Site
Kita-gun, Kagawa-ken
Research Site
Kobe, Hyōgo
Research Site
Kyoto, Kyoto
Research Site
Maebashi, Gunma
Research Site
Matsuyama, Ehime
Research Site
Meguro-ku, Tokyo
Research Site
Mitaka, Tokyo
Research Site
Nagasaki, Nagasaki
Research Site
Narashino, Chiba
Research Site
Ōita, Oita Prefecture
Research Site
Osaka, Osaka
Research Site
Ōsaka-sayama, Osaka
Research Site
Ōtake, Hiroshima
Research Site
Sagamihara, Kanagawa
Research Site
Sapporo, Hokkaido
Research Site
Sendai, Miyagi
Research Site
Shinjuku-ku, Tokyo
Research Site
Suita, Osaka
Research Site
Sunto-gun, Shizuoka
Research Site
tabashi City, Tokyo
Research Site
Tsukuba, Ibaraki
Research Site
Wako, Saitama
United States19 sites
Research Site
Burlington, Vermont
Research Site
Canton, Ohio
Research Site
Des Moines, Iowa
Research Site
Gainsville, Florida
Research Site
Greenbrae, California
Research Site
Los Angeles, California
Research Site
Milwaukee, Wisconsin
Research Site
Nashville, Tennessee
Research Site
Norfolk, Virginia
Research Site
Norwich, Connecticut
Research Site
Palm Springs, California
Research Site
Pittsburgh, Pennsylvania
Research Site
Port St.Lucie, Florida
Research Site
Salt Lake City, Utah
Research Site
San Mateo, California
Research Site
Seattle, Washington
Research Site
Tucson, Arizona
Research Site
Washington D.C., District of Columbia
Research Site
Wheeling, West Virginia
Canada19 sites
Research Site
Barrie, Ontario
Research Site
Burlington, Ontario
Research Site
Calgary, Alberta
Research Site
Edmonton, Alberta
Research Site
Granby, Quebec
Research Site
Hamilton, Ontario
Research Site
Kentville, Nova Scotia
Research Site
Kitchener, Ontario
Research Site
Laval, Quebec
Research Site
London, Ontario
Research Site
Mississauga, Ontario
Research Site
Montreal, Quebec
Research Site
North York, Ontario
Research Site
Oakville, Ontario
Research Site
Ottawa, Ontario
Research Site
Point-Claire, Quebec
Research Site
Québec, Quebec
Research Site
Toronto, Ontario
Research Site
Vancouver, British Columbia
Germany11 sites
Research Site
Augsburg, Augsburg
Research Site
Bad Gegeberg, Bad Gegeberg
Research Site
Berlin, State of Berlin
Research Site
Emmendingen, Emmendingen
Research Site
Kirchheim, Teck
Research Site
Leipzig, Leipzig
Research Site
Lübeck, Luebeck
Research Site
Mannheim, Mannheim
Research Site
München, Muenchen
Research Site
Planegg, Muenchen
Research Site
Reutlingen, Reutlingen
India11 sites
Research Site
Bhopal, Madhya Pradesh
Research Site
Bikaner, Rajasthan
Research Site
Chandigarh, Punjab
Research Site
Gujarat, Gujarat
Research Site
Jaipur, Rajasthan
Research Site
Kolkota, West Bengal
Research Site
Ludhiana, Punjab
Research Site
Mumbai, Maharashtra
Research Site
New Delhi, New Delhi
Research Site
Rohini, National Capital Territory of Delhi
Research Site
Trivandrum, Kerala
China9 sites
Research Site
Haidian District, Beijing Municipality
Research Site
Nanjing, Jiangsu
Research Site
Pudong New Area, Shanghai Municipality
Research Site
Shanghai, Shanghai Municipality
Research Site
Wuhan, Hubei
Research Site
XI Cheng District, Beijing Municipality
Research Site
Xi’an, Shanxi
Research Site
Xicheng District, Beijing Municipality
Research Site
Xuhui District, Shanghai Municipality
Brazil8 sites
Research Site
Belo Horizonte, Minas Gerais
Research Site
Curitiba, Paraná
Research Site
Fortaleza, Ceará
Research Site
Goiânia, Goiás
Research Site
Porto Alegre, Rio Grande do Sul
Research Site
Ribeirão Preto, São Paulo
Research Site
Santo André, São Paulo
Research Site
São Paulo, São Paulo
Russia8 sites
Research Site
Barnaul, Barnaul
Research Site
Izhevsk, Izhevsk
Research Site
Kursk, Kursk Oblast
Research Site
Moscow, Moscow
Research Site
Saint Petersgurg, Saint Petersgurg
Research Site
Sochi, Sochi
Research Site
Stary Oskol, Belgorod Oblast
Research Site
Voronezh, Voronezh Oblast
France6 sites
Research Site
Montpellier, Montpellier
Research Site
Paris, Paris
Research Site
Poitiers, Poitiers Cedex
Research Site
Suresnes, Suresnes
Research Site
Toulouse, Toulouse
Research Site
Villejuif, Villejuif
Poland6 sites
Research Site
Bialystok, Bialystok
Research Site
Kościerzyna, Koscierzyna
Research Site
Krakow, Krakow
Research Site
Rzeszów, Rzeszow
Research Site
Warsaw, Warszawa
Research Site
Wroclaw, Wroclaw
Australia5 sites
Research Site
Ashford, South Australia
Research Site
Hornsby, New South Wales
Research Site
Redcliffe, Queensland
Research Site
St Leonards, New South Wales
Research Site
Subiaco, Western Australia
Hungary5 sites
Research Site
Budapest, Budapest
Research Site
Debrecen, Debrecen
Research Site
Miskolc, Miskolc
Research Site
Nyíregyháza, Nyiregyhaza
Research Site
Szeged, Szeged
South Korea5 sites
Research Site
Gangnam-gu, Seoul
Research Site
Heungduk-gu Cheongju, North Chungcheong
Research Site
Seo-gu, Busan
Research Site
Seongnam-si, Gyeonggi-do
Research Site
Songpa-gu, Seoul
United Kingdom5 sites
Research Site
Cambridge, Cambridgeshire
Research Site
Huddersfield, Yorkshire
Research Site
London, London
Research Site
Maidstone, Kent
Research Site
Reading, Berkshire
Belgium4 sites
Research Site
Brussels, Brussels Capital
Research Site
Ghent, Gent
Research Site
Kortrijk, Kortrijk
Research Site
Leuven, Leuven
Czechia4 sites
Research Site
Brno, Brno
Research Site
Olomouc, Olomouc
Research Site
Prague, Prague
Research Site
Ústí nad Labem, Usti nad Labem
Denmark4 sites
Research Site
Aalborg, Aalborg
Research Site
Aarhus, Aarhus
Research Site
Copenhagen, Kobenhavn
Research Site
Herlev, Herlev
Netherlands4 sites
Research Site
Amsterdam, Amsterdam
Research Site
Eindhoven, Eindhoven
Research Site
Groningen, Provincie Groningen
Research Site
Nijmegen, Nijmegen
South Africa4 sites
Research Site
Bloemfontein, Bloemfontein
Research Site
Pietermaritzburg, Pietermaritzburg
Research Site
Port Elizabeth, Port Elizabeth
Research Site
Tygerberg, Cape Town
Switzerland4 sites
Research Site
Basel, Basel
Research Site
Bern, Canton of Bern
Research Site
Locarno, Locarno
Research Site
Sursee, Sursee
Finland3 sites
Research Site
Joensuu, Joensuu
Research Site
Kajaanintie, Kajaanintie
Research Site
Tampere, Pirkanmaa
Hong Kong3 sites
Research Site
Hong Kong, Hong Kong
Research Site
Shatin, Shatin
Research Site
Tuenmen, Hong Kong
Mexico3 sites
Research Site
Distrito Federal Ciudad, Mexico
Research Site
Metepec, State of Mexico
Research Site
Mexico City, Mexico City
Portugal3 sites
Research Site
Coimbra, Coimbra District
Research Site
Lisbon, Lisbon District
Research Site
Porto, Porto District
Serbia3 sites
Research Site
Belgrade, Belgrade
Research Site
Niš, Nis
Research Site
Novi Sad, Novi Sad
Sweden3 sites
Research Site
Gothenburg, Goteborg
Research Site
Gothenburg, Gothenburg
Research Site
Stockholm, Stockholm County
Taiwan3 sites
Research Site
Kaohsiung City, Kaohsiung
Research Site
Taipei, Taipei
Research Site
Taoyuan, Taiwan
Argentina2 sites
Research Site
Buenos Aires, Buenos Aires
Research Site
Santa Fe, Santa Fe Province
About this study
Official title: A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
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.
- Conditions
- Prostate Cancer
- Being tested
- ZD4054, Placebo
- Keywords
- Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZD4054Drug
Also called Zibotentan
ZD4054 10 mg oral tablet once daily
PlaceboDrug
Matching placebo oral tablet once daily
| Study group | Role | What they receive |
|---|---|---|
| ZD4054 | Experimental | ZD4054 10 mg oral tablet once daily Receives: Drug: ZD4054 |
| Placebo | Placebo comparator | Matching Placebo, oral tablets once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method
Measured: From date of randomization until date of death, assessed up to 32 months
Secondary outcomes (9)
Progression Free Survival
Median time (in months) from randomisation until clinical progression of disease, 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, using the Kaplan-Meier method
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months
Time to Use of Opiates
Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method
Measured: From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months
Incidence of Skeletal Related Events
Median time (in months) from randomisation until occurrence of a skeletal related event, where skeletal related event is defined as the first occurrence of a pathological fracture, a vertebral compression fracture not related to trauma, prophylactic surgery or radiation for impending fracture or spinal cord compression, or a spinal cord compression, using the Kaplan-Meier method.
Measured: From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Bone Metastases Formation
Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method
Measured: Patients were assessed every 12 weeks
Health Related Quality of Life
Median time (in months) from randomisation until deterioration of Health related Quality of Life using the Kaplan-Meier method, where deterioration is defined as a change from baseline of less than or equal to -6 points in Total FACT-P score maintained for 2 consecutive visits.
Measured: Patients were assessed at every visit
Time to Prostate-specific Antigen (PSA) Progression
Median time (in months) from randomisation to first PSA value >50% higher than baseline of at least 5ng/ml seen in at least 2 consecutive PSA values at least 2 weeks apart using the Kaplan-Meier method.
Measured: Patients were assessed every 12 weeks
Time to Pain Progression
Median time (in months) from randomisation to first assessment of an increased pain event, where increased pain event is defined as the first of a patient requiring opiate medication for duration of ≥1 week for pain due to prostate cancer metastasis, pain due to metastasis that has an increase in the worst pain item of the Brief Pain Inventory (BPI) from baseline to a minimum score of 5 with no decrease in analgesic use, or pain due to metastasis requiring radionuclide therapy, radiation therapy or surgery.
Measured: Patients were assessed every 12 weeks
Time to Initiation of Chemotherapy
Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method
Measured: Patients were assessed every 12 weeks
Pharmacokinetic Characteristics of ZD4054
Measured: PK samples were performed at randomisation, Week 4, Week 8 and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJul 2010
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 896 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Gleave, MD, FRCSC, FACS, Principal investigator, The Prostate Centre at Vancouver General HospitalJoel B Nelson, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554229
- Sponsor's protocol ID
- D4320C00014
- Other IDs
- 2007-003227-20
- Acronym
- ENTHUSE M1
- Status last verified
- Apr 2012
- First submitted
- 2 Nov 2007
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Trial to Test the Efficacy of ZD4054(Zibotentan), an Endothelin A Receptor Antagonist, Versus Placebo in Patients With Hormone Resistant Prostate Cancer (HRPC) and Bone Metastasis Who Are Pain Free and Mildly Symptomatic.
- ClinicalTrials.gov ID
- NCT00554229
- Acronym / sponsor ID
- ENTHUSE M1 / D4320C00014
- Conditions
- Prostate Cancer
- Keywords
- Hormone Resistant Prostate Cancer, Endothelin A Receptor Antagonist, Endothelin A, Endothelin A antagonist
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 6 Nov 2007 (estimated)
- Results
- Posted 31 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZD4054 | Experimental | Drug: ZD4054ZD4054 10 mg oral tablet once daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo, oral tablets once daily |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who answer TRUE to the following criteria may be eligible to participate in this trial.
- Confirmed diagnosis of prostate cancer (adenocarcinoma of the prostate) that has spread to the bone (bone metastases)
- Increasing Prostate Specific Antigen (PSA) over a one month period
- No pain, or mild pain from prostate cancer
- Currently receiving treatment with surgical or medical castration
Key exclusion criteria (5 listed)
- Patients who answer TRUE to the following may NOT eligible to participate in this trial.
- Currently using opiates based pain killers)
- Previous treatment with chemotherapy (paclitaxel, docetaxel, and mitoxantrone)
- Suffering from heart failure or had a myocardial infarction within last 6 months
- A history of epilepsy or seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZD4054Also: ZibotentanZD4054 10 mg oral tablet once daily | Drug | ZD4054 |
| PlaceboMatching placebo oral tablet once daily | Drug | Placebo |
Primary outcome
Overall Survival
Time frame: From date of randomization until date of death, assessed up to 32 months
Median time (in months) from randomisation until death using the Kaplan-Meier method
9 secondary outcomes
Progression Free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 31 months
Time to Use of Opiates
Time frame: From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months
Incidence of Skeletal Related Events
Time frame: From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Bone Metastases Formation
Time frame: Patients were assessed every 12 weeks
Health Related Quality of Life
Time frame: Patients were assessed at every visit
Time to Prostate-specific Antigen (PSA) Progression
Time frame: Patients were assessed every 12 weeks
Time to Pain Progression
Time frame: Patients were assessed every 12 weeks
Time to Initiation of Chemotherapy
Time frame: Patients were assessed every 12 weeks
Pharmacokinetic Characteristics of ZD4054
Time frame: PK samples were performed at randomisation, Week 4, Week 8 and Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Gleave, MD, FRCSC, FACS principal investigator
The Prostate Centre at Vancouver General Hospital
Joel B Nelson, MD principal investigator
University of Pittsburgh
197 sites in 31 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ZD4054 in people with Prostate Cancer, run by AstraZeneca at 197 sites in 31 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 197 sites in Japan, United States, Canada, Germany, India and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: From date of randomization until date of death, assessed up to 32 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.