Window Study of ZD4054 in Metastatic Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Assessment of the Effects of the Specific Endothelin-A Antagonist ZD4054 on Prostate Cancer Biomarkers in Patients With Castrate-resistant Metastatic Disease

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01168141
• Other study ID #: 08_CLPHA_54
• Status: Enrolling by invitation
• Phase: N/A
• First received: July 20, 2010
• Last updated: July 22, 2010
• Start date: July 2009
• Est. completion date: September 2010

Study information

• Verified date: June 2010
• Source: Christie Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Metastasis
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• ZD4054
10mg ZD4054 daily in tablet form

Locations

Country	Name	City	State
United Kingdom	The Christie NHS Foundation Trust	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Christie Hospital NHS Foundation Trust	AstraZeneca

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in tissue biomarkers		6 weeks	No
Primary	Changes in blood-borne biomarkers		12 weeks	No
Primary	Changes in imaging biomarkers		12 weeks	No