Window Study of ZD4054 in Metastatic Prostate Cancer

This study is enrolling participants by invitation only.

Sponsor:

Collaborator:

AstraZeneca

Information provided by:

Christie Hospital NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT01168141

First received: July 20, 2010

Last updated: July 22, 2010

Last verified: June 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	July 20, 2010
Last Updated Date	July 22, 2010
Start Date ^ICMJE	July 2009
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 22, 2010)	Changes in tissue biomarkers [ Time Frame: 6 weeks ] [ Designated as safety issue: No ] Changes in blood-borne biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ] Changes in imaging biomarkers [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01168141 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Window Study of ZD4054 in Metastatic Prostate Cancer
Official Title ^ICMJE	Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Prostate Cancer Metastasis
Intervention ^ICMJE	Drug: ZD4054 10mg ZD4054 daily in tablet form Other Name: Zibotentan
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	30
Estimated Completion Date	September 2010
Estimated Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Male
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT01168141
Other Study ID Numbers ^ICMJE	08_CLPHA_54
Has Data Monitoring Committee	No
Responsible Party	Ms Angela Ball, Christie NHS Foundation Trust
Study Sponsor ^ICMJE	Christie Hospital NHS Foundation Trust
Collaborators ^ICMJE	AstraZeneca
Investigators ^ICMJE	Not Provided
Information Provided By	Christie Hospital NHS Foundation Trust
Verification Date	June 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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