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Window Study of ZD4054 in Metastatic Prostate Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by The Christie NHS Foundation Trust.
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT01168141
First Posted: July 23, 2010
Last Update Posted: July 23, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
The Christie NHS Foundation Trust
  Purpose
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.

Condition Intervention
Prostate Cancer Metastasis Drug: ZD4054

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease

Resource links provided by NLM:


Further study details as provided by The Christie NHS Foundation Trust:

Primary Outcome Measures:
  • Changes in tissue biomarkers [ Time Frame: 6 weeks ]
  • Changes in blood-borne biomarkers [ Time Frame: 12 weeks ]
  • Changes in imaging biomarkers [ Time Frame: 12 weeks ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ZD4054
    10mg ZD4054 daily in tablet form
    Other Name: Zibotentan
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168141


Locations
United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Sponsors and Collaborators
The Christie NHS Foundation Trust
AstraZeneca
  More Information

Responsible Party: Ms Angela Ball, Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01168141     History of Changes
Other Study ID Numbers: 08_CLPHA_54
First Submitted: July 20, 2010
First Posted: July 23, 2010
Last Update Posted: July 23, 2010
Last Verified: June 2010

Keywords provided by The Christie NHS Foundation Trust:
Castrate-resistant prostate cancer with bone metastasis

Additional relevant MeSH terms:
Prostatic Neoplasms
Neoplasm Metastasis
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplastic Processes
Pathologic Processes