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

July 20, 2010
July 22, 2010
July 2009
September 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01168141 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Window Study of ZD4054 in Metastatic Prostate Cancer
Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Prostate Cancer
  • Metastasis
Drug: ZD4054
10mg ZD4054 daily in tablet form
Other Name: Zibotentan
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
30
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01168141
08_CLPHA_54
No
Ms Angela Ball, Christie NHS Foundation Trust
Christie Hospital NHS Foundation Trust
AstraZeneca
Not Provided
Christie Hospital NHS Foundation Trust
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP