Prostate CancerPhase 3ENTHUSE M1CNCT00617669

A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) and Docetaxel in Metastatic Hormone Resistant Prostate Cancer

A Phase 3 study testing Docetaxel and ZD4054 in people with Prostate Cancer, run by AstraZeneca at 147 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Enthuse M1C is a large phase III clinical trial studying the safety and efficacy of ZD4054 (Zibotentan) in combination with docetaxel (Taxotere) in patients with metastatic hormone resistant prostate cancer (HRPC). 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?: Docetaxel and ZD4054
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,494 participants
Where: 147 sitesin 26 countries
Study dates: Jan 2008to Jul 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 metastasis)
Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
Currently receiving treatment with surgical or medical castration

Who cannot join

Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
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

Trial locations and contacts

147 sites in 26 countries.

Country

City, postcode or hospital

147 sites in 26 countries

United States25 sites

Research Site
Canton, Ohio
Research Site
Chapel Hill, North Carolina
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Charleston, South Carolina
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Chattanooga, Tennessee
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Cincinnati, Ohio
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Durham, North Carolina
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Fort Myers, Florida
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Gainsville, Florida
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Greenbrae, California
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Lincoln, Nebraska
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Nashville, Tennessee
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Norwich, Connecticut
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Ocala, Florida
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Omaha, Nebraska
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Pittsburgh, Pennsylvania
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PORTUGALt Saint Lucie, Florida
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Richmond, Virginia
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Rockville, Maryland
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San Antonio, Texas
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San Diego, California
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Seattle, Washington
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Washington D.C., District of Columbia
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Winston-Salem, North Carolina

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Brazil11 sites

Research Site
Belo Horizonte, Minas GERMANYais
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Curitiba, Parana/ Brazil
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Fortaleza, Ceara/ LA
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Goiânia, Goias/ LA
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Goiânia, Goiás
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Londrina, Paraná
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PORTUGALto Alegre, Rio Grande Do Sul/ LA
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Ribeirão Preto, Sao Paulo/ LA
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Rio de Janeiro, Rio de Janeiro
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Santo André, São Paulo
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São Paulo, São Paulo

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Germany11 sites

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Berlin
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Bonn
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Dresden
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Emmendingen
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Hanover, GERMANYmany
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Kirchheim-Teck
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Leipzig
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Lübeck
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Münster
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Tübingen
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Wuppertal

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India11 sites

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Bangalore, Karnataka
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Bhopal, Madhya Pradesh
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Bikaner, Rajasthan
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Delhi
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Jaipur, Rajasthan
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Kolkata, West Bengal
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Kolkota, West Bengal
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New Delhi
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Pune, Maharashtra
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Trivandrum, Kerala
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Vellore, Tamil Nadu

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Australia9 sites

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Ashford, South Australia
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Darlinghurst, New South Wales
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Footscray, Victoria
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Perth, Western Australia
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Redcliffe, Queensland
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St Leonards, New South Wales
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Subiaco, Western Australia
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Wodonga, Victoria
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Wollongong, New South Wales

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France8 sites

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La Roche-sur-Yon, FRANCEnce
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Marseille, FRANCEnce
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Paris, FRANCEnce
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Paris, Paris
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Paris
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Reims, FRANCEnce
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Saint-Herblain, Saint Herblain
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Villejuif, FRANCEnce

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Czechia7 sites

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Brno, Czechoslovakia Republic
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Jablonec nad Nisou
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Kroměříž
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Olomouc, Czech Republic
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Prague, Czech Republic
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Prague
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Ústí nad Labem, Czech Republic

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Canada6 sites

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Halifax, Nova Scotia
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London, Ontario
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Québec, Quebec
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Sherbrooke, Quebec
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Toronto, Ontario
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Winnipeg, Manitoba

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Hungary5 sites

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Budapest, HUNGARYary
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Győr, HUNGARYary
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Miskolc, HUNGARYary
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Ny Regyh Za, HUNGARYary
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Szeged, HUNGARYary

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Poland5 sites

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Kościerzyna
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Lublin, POLANDand
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Swidnica, POLANDand
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Warszaa, POLANDand
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Wroclaw

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Russia5 sites

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Barnaul, RUSSIAsia
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Izhevsk, RUSSIAsia
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Kursk, RUSSIAsia
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Sochi, RUSSIAsia
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Voronezh, RUSSIAsia

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South Africa5 sites

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Bloemfontein
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Overport, Durban
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Panorama, Cape Town
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Port Elizabeth
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TyGERberg, Cape Town

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South Korea5 sites

Research Site
Cheongju-si, North Chungcheong
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Ilsandong-gu, Goyang-si, Gyeonggi-do
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Nowon-gu, Seoul
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Seodaemun-gu, Seoul
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Songpa-gu, Seoul

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Peru4 sites

Research Site
Callao
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Cercado, Arequipa
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Cercado de Arequipa, Arequipa
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Lima

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United Kingdom4 sites

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London
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Manchester, Manchester
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Reading, Berkshire
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Westgate Road, Newcastle Upon Tyne

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Argentina3 sites

Research Site
Bahía Blanca, Buenos Aires
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Buenos Aires, Buenos Aires
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Santa Fe, Santa Fe Province

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Finland3 sites

Research Site
Helsinki, Finland
Research Site
Joensuu
Research Site
Seinäjoki

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Italy3 sites

Research Site
Genoa, Italy
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Lugo (RA), Italy
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Rome, Italy

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Romania3 sites

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Bucharest
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Sibiu
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Timișoara

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Switzerland3 sites

Research Site
Aarau
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Locarno
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Sursee

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Portugal2 sites

Research Site
Coimbra, PORTUGALtugal
Research Site
PORTUGALto, PORTUGALtugal

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Serbia2 sites

Research Site
Belgrade, SERBIAbia
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Niš, SERBIAbia

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Spain2 sites

Research Site
Madrid, Spain
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Valencia, Spain

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Sweden2 sites

Research Site
Stockholm, Sweden
Research Site
Uppsala

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Taiwan2 sites

Research Site
Kaohsiung City, TAIWANwan
Research Site
TAIWANpei, TAIWANwan

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Netherlands1 site

Research Site
Nijmegen

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About this study

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer

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.

Conditions: Prostate Cancer
Being tested: Docetaxel, 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.

DocetaxelDrug
Also called Taxotere®
intravenous infusion given every three weeks
ZD4054Drug
Also called Zibotentan
10 mg oral once daily dose
PlaceboDrug
placebo oral tablet once daily

Study groups in NCT00617669
Study group	Role	What they receive
Placebo + Docetaxel	Active comparator	placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks Receives: Drug: Docetaxel; Drug: Placebo
ZD4054 + Docetaxel	Experimental	ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks Receives: Drug: Docetaxel; Drug: ZD4054

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: Patients were followed for survival up to 40 months

Secondary outcomes (7)

Progression Free Survival
Median time (in months) from randomisation until clinical progression of disease using the Kaplan-Meier method. 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
Measured: Patients were followed for progression up to 40 months
Incidence of Skeletal Related Events
Median time (in months) from randomisation until occurrence of a skeletal related event using the Kaplan-Meier method, 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.
Measured: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Prostate-specific Antigen (PSA) Progression
Median time (in months) from randomisation until 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: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Pain Progression
Median time (in months) from randomisation until date of first assessment of increased pain using the Kaplan-Meier method, 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: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Pain Response
Number of patients with a pain response, defined as a decrease in brief pain inventory questionnaire (BPI) of at least 2 points from baseline or a decrease in opiate use of 25% from baseline.
Measured: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
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: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
PSA Response
PSA response defined as >50% decrease in serum PSA values from baseline seen in at least 2 consecutive PSA values at least 2 weeks apart.
Measured: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2008Jul 2011

First posted18 Feb 2008 (estimated)
Study startJan 2008
Primary completionMay 2011
Study completionJul 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.
Publications (1)Papers the sponsor has linked to this study.
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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 1,494 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00617669
Sponsor's protocol ID: D4320C00033
Acronym: ENTHUSE M1C
Status last verified: Apr 2012
First submitted: 24 Jan 2008
Last updated: 10 Sep 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23569308

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 (Zibotentan) in Combination With Docetaxel in Comparison With Docetaxel in Patients With Metastatic Hormone-resistant Prostate Cancer
ClinicalTrials.gov ID: NCT00617669
Acronym / sponsor ID: ENTHUSE M1C / D4320C00033
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: 1,494 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: May 2011 (actual)
Study completion: Jul 2011 (actual)
First posted: 18 Feb 2008 (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.

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

No patients will be deprived of standard prostate cancer therapy.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo + Docetaxel	Active comparator	Drug: Docetaxel, Drug: Placeboplacebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
ZD4054 + Docetaxel	Experimental	Drug: Docetaxel, Drug: ZD4054ZD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 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 metastasis)
Increasing Prostate Specific Antigen (PSA), collected within one year of enrollment
Currently receiving treatment with surgical or medical castration

Key exclusion criteria (4 listed)

Patients who answer TRUE to the following ARE NOT eligible to participate in this trial.
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

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
DocetaxelAlso: Taxotere®intravenous infusion given every three weeks	Drug	Placebo + Docetaxel, ZD4054 + Docetaxel
ZD4054Also: Zibotentan10 mg oral once daily dose	Drug	ZD4054 + Docetaxel
Placeboplacebo oral tablet once daily	Drug	Placebo + Docetaxel

Primary outcome

Overall Survival
Time frame: Patients were followed for survival up to 40 months
Median time (in months) from randomisation until death using the Kaplan-Meier method.

7 secondary outcomes

Progression Free Survival
Time frame: Patients were followed for progression up to 40 months
Incidence of Skeletal Related Events
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Prostate-specific Antigen (PSA) Progression
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Time to Pain Progression
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Pain Response
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
Health Related Quality of Life
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)
PSA Response
Time frame: While receiving docetaxel study visits were aligned with its administration ie every 3weeks, after 12 weeks and completion of docetaxel therapy every 12 weeks (up to 40 months)

Results and safety

Results posted to the registry on 31 May 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ZD4054 + Docetaxel	524	94
Placebo + Docetaxel	528	77

Primary outcome: Overall Survival

Time frame: Patients were followed for survival up to 40 months. Median (Inter-Quartile Range). Unit: Months

Measure	ZD4054 + Docetaxel n = 524	Placebo + Docetaxel n = 528
Value	20.0 (11.6 to 32.0)	19.2 (12.0 to 30.3)

Population analysed: Full Analysis Set

7 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ZD4054 + Docetaxel	214 of 522 (41%)	490 of 522 (93.9%)	Not reported
Placebo + Docetaxel	203 of 525 (38.7%)	483 of 525 (92%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23569308Fizazi 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.

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Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
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Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
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Enrolling by invitationObservational study
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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
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Recruiting
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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.

Karim Fizazi, MD, PhD principal investigator

Gustave Roussy, Cancer Campus, Grand Paris

Judd W Moul, MD, FACS principal investigator

Duke University

147 sites in 26 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Docetaxel and ZD4054 in people with Prostate Cancer, run by AstraZeneca at 147 sites in 26 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 4 inclusion and 4 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 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 147 sites in United States, Brazil, Germany, India, Australia and 21 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. 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: Patients were followed for survival up to 40 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00617669, which also lists 1 linked publication.

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 10 Sep 2012.