Back to resultsWindow Study of ZD4054 in Metastatic Prostate Cancer
Primary Purpose
Prostate Cancer, Metastasis
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ZD4054
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring Castrate-resistant prostate cancer with bone metastasis
Eligibility Criteria
Inclusion Criteria:
- histological confirmation of prostate adenocarcinoma
- documented evidence of bone metastasis on bone scan or MRI
- biochemical progression of prostate cancer
- surgically or medically castrate with serum testosterone ≤2.4nmol/L
- ECOG performance status 0 - 2
- life expectancy of 6 months or more.
Exclusion Criteria:
- radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
- prior targeted cancer therapies (such as gefitinib, bevacizumab)
- systemic radionuclide therapy within 12 weeks of starting study treatment.
- current therapy, within 4 weeks of study entry with potent inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
- definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
- ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents
Sites / Locations
- The Christie NHS Foundation Trust
Outcomes
Primary Outcome Measures
Changes in tissue biomarkers
Changes in blood-borne biomarkers
Changes in imaging biomarkers
Secondary Outcome Measures
Full Information
NCT ID
NCT01168141
First Posted
July 20, 2010
Last Updated
July 22, 2010
Sponsor
The Christie NHS Foundation Trust
Collaborators
AstraZeneca
1. Study Identification
Unique Protocol Identification Number
NCT01168141
Brief Title
Window Study of ZD4054 in Metastatic Prostate Cancer
Official Title
Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
The Christie NHS Foundation Trust
Collaborators
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a prospective study in which patients with castrate-resistant prostate cancer and bone metastases will undergo imaging, donate blood, bone marrow and urine samples, and where possible primary tumour and bone metastatic tissue, before and during treatment with ZD4054, an orally active specific endothelin-A antagonist. The samples will be used primarily for biomarker studies, and it is hypothesized that these will inform on the mechanism of action of this drug. Magnetic Resonance Imaging (MRI) will be performed to evaluate emerging functional imaging endpoints as markers of early response in bone metastatic prostate cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Metastasis
Keywords
Castrate-resistant prostate cancer with bone metastasis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD4054
Other Intervention Name(s)
Zibotentan
Intervention Description
10mg ZD4054 daily in tablet form
Primary Outcome Measure Information:
Title
Changes in tissue biomarkers
Time Frame
6 weeks
Title
Changes in blood-borne biomarkers
Time Frame
12 weeks
Title
Changes in imaging biomarkers
Time Frame
12 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histological confirmation of prostate adenocarcinoma
documented evidence of bone metastasis on bone scan or MRI
biochemical progression of prostate cancer
surgically or medically castrate with serum testosterone ≤2.4nmol/L
ECOG performance status 0 - 2
life expectancy of 6 months or more.
Exclusion Criteria:
radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment.
prior targeted cancer therapies (such as gefitinib, bevacizumab)
systemic radionuclide therapy within 12 weeks of starting study treatment.
current therapy, within 4 weeks of study entry with potent inhibitors of CYP3A4 (ketoconazole, itraconazole, ritonavir, indinavir, erythromycin, troleandomycin, clarithromycin, diltiazem and verapamil), inhibitors of CYPs 2D6 and 2C9 (quinidine and fluconazole), and potent P450 inducers (phenytoin, rifampicin, carbamazepine and phenobarbitone)
definite or suspected personal history or family history of adverse drug reactions, or hypersensitivity to drugs that are endothelin antagonists
ineligibility for MRI scanning includes standard MRI criteria (for example, metal implants such as cochlear implants, cardiac pacemakers, heart valves, aneurysm clips and metal fragments in eyes) and patients known to be allergic to gadolinium-based MRI contrast agents
Facility Information:
Facility Name
The Christie NHS Foundation Trust
City
Manchester
Country
United Kingdom
12. IPD Sharing Statement
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Window Study of ZD4054 in Metastatic Prostate Cancer
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