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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01168141

Enrollment

Registered

2010-07-23

Start date

2009-07-31

Completion date

2010-09-30

Last updated

2010-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer, Metastasis

Keywords

Castrate-resistant prostate cancer with bone metastasis

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.

Interventions

DRUGZD4054

10mg ZD4054 daily in tablet form

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Changes in tissue biomarkers	6 weeks
Changes in blood-borne biomarkers	12 weeks
Changes in imaging biomarkers	12 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026