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
  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: 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 Christie Hospital NHS Foundation Trust:

Primary Outcome Measures:
  • 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 ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01168141

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

No publications provided

Responsible Party: Ms Angela Ball, Christie NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01168141     History of Changes
Other Study ID Numbers: 08_CLPHA_54
Study First Received: July 20, 2010
Last Updated: July 22, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

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

ClinicalTrials.gov processed this record on September 22, 2014