Back to resultsA Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases (ENTHUSE M1)
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ZD4054
Placebo
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 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
Exclusion Criteria:
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
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ZD4054
Placebo
Arm Description
ZD4054 10 mg oral tablet once daily
Matching Placebo, oral tablets once daily
Outcomes
Primary Outcome Measures
Overall Survival
Median time (in months) from randomisation until death using the Kaplan-Meier method
Secondary Outcome Measures
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
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
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.
Bone Metastases Formation
Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method
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.
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.
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.
Time to Initiation of Chemotherapy
Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method
Pharmacokinetic Characteristics of ZD4054
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00554229
Brief Title
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
Acronym
ENTHUSE M1
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 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 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.
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 ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
896 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZD4054
Arm Type
Experimental
Arm Description
ZD4054 10 mg oral tablet once daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching Placebo, oral tablets once daily
Intervention Type
Drug
Intervention Name(s)
ZD4054
Other Intervention Name(s)
Zibotentan
Intervention Description
ZD4054 10 mg oral tablet once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo oral tablet once daily
Primary Outcome Measure Information:
Title
Overall Survival
Description
Median time (in months) from randomisation until death using the Kaplan-Meier method
Time Frame
From date of randomization until date of death, assessed up to 32 months
Secondary Outcome Measure Information:
Title
Progression Free Survival
Description
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
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
Title
Time to Use of Opiates
Description
Median time (in months) from randomisation until use of opiates for disease-related symptoms for a duration ≥1 week using the Kaplan-Meier method
Time Frame
From date of randomization until use of opiates for disease-related symptoms for a duration ≥1 week, assessed up to 31 months
Title
Incidence of Skeletal Related Events
Description
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.
Time Frame
From date of randomization until occurrence of a skeletal related event, assessed up to 31 months
Title
Bone Metastases Formation
Description
Median time (in months) from randomisation to appearance of ≥4 new bone lesions using the Kaplan-Meier method
Time Frame
Patients were assessed every 12 weeks
Title
Health Related Quality of Life
Description
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.
Time Frame
Patients were assessed at every visit
Title
Time to Prostate-specific Antigen (PSA) Progression
Description
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.
Time Frame
Patients were assessed every 12 weeks
Title
Time to Pain Progression
Description
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.
Time Frame
Patients were assessed every 12 weeks
Title
Time to Initiation of Chemotherapy
Description
Median time (in months) from randomisation to first administration of any chemotherapy using the Kaplan-Meier method
Time Frame
Patients were assessed every 12 weeks
Title
Pharmacokinetic Characteristics of ZD4054
Time Frame
PK samples were performed at randomisation, Week 4, Week 8 and Week 12
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 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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Gleave, MD, FRCSC, FACS
Organizational Affiliation
The Prostate Centre at Vancouver General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joel B Nelson, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
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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
Mitaka-City
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Nagasaki
Country
Japan
Facility Name
Research Site
City
Heungduk-gu Cheongju
State/Province
Chungbuk
Country
Korea, Republic of
Facility Name
Research Site
City
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
Songpa-gu
State/Province
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Metepec
State/Province
Estado de Mexico
Country
Mexico
Facility Name
Research Site
City
Distrito Federal Ciudad
Country
Mexico
Facility Name
Research Site
City
Mexico City
Country
Mexico
Facility Name
Research Site
City
Amsterdam
Country
Netherlands
Facility Name
Research Site
City
Eindhoven
Country
Netherlands
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Nijmegen
Country
Netherlands
Facility Name
Research Site
City
Bialystok
Country
Poland
Facility Name
Research Site
City
Koscierzyna
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Rzeszow
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
Lisboa
Country
Portugal
Facility Name
Research Site
City
Porto
Country
Portugal
Facility Name
Research Site
City
Stary Oskol
State/Province
Belgorodskaya region
Country
Russian Federation
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Izhevsk
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. Petersgurg
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
Singapore
Country
Singapore
Facility Name
Research Site
City
Tygerberg
State/Province
Cape Town
Country
South Africa
Facility Name
Research Site
City
Bloemfontein
Country
South Africa
Facility Name
Research Site
City
Pietermaritzburg
Country
South Africa
Facility Name
Research Site
City
Port Elizabeth
Country
South Africa
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Gothenburg
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Bern
Country
Switzerland
Facility Name
Research Site
City
Locarno
Country
Switzerland
Facility Name
Research Site
City
Sursee
Country
Switzerland
Facility Name
Research Site
City
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Taoyuan
Country
Taiwan
Facility Name
Research Site
City
Reading
State/Province
Berkshire
Country
United Kingdom
Facility Name
Research Site
City
Cambridge
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Research Site
City
Maidstone
State/Province
Kent
Country
United Kingdom
Facility Name
Research Site
City
Huddersfield
State/Province
Yorkshire
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Phase III Trial of ZD4054 (Zibotentan) (Endothelin A Antagonist) in Hormone Resistant Prostate Cancer With Bone Metastases
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