Window Study of ZD4054 in Metastatic Prostate Cancer

The Christie NHS Foundation Trust

Status

Unknown

Conditions

Metastasis

Prostate Cancer

Treatments

Drug: ZD4054

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01168141

08_CLPHA_54

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

No 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