Window Study of ZD4054 in Metastatic Prostate Cancer

Not Applicable

• Conditions: Prostate Cancer; Metastasis

• Registration Number: NCT01168141
• Lead Sponsor: The Christie NHS Foundation Trust

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 available

Study Timeline

• Study Start: 2009-07
• Status Verified: 2010-06
• Study First Submitted: 2010-07-20
• Study First Submitted QC: 2010-07-22
• Last Update Submitted: 2010-07-22
• Study First Posted: 2010-07-23
• Last Update Posted: 2010-07-23
• Primary Completion: 2010-09
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in tissue biomarkers	6 weeks
Changes in blood-borne biomarkers	12 weeks
Changes in imaging biomarkers	12 weeks

Trial Locations

Locations (1)

The Christie NHS Foundation Trust; 🇬🇧 Manchester, United Kingdom