Status:
UNKNOWN
Window Study of ZD4054 in Metastatic Prostate Cancer
Lead Sponsor:
The Christie NHS Foundation Trust
Collaborating Sponsors:
AstraZeneca
Conditions:
Prostate Cancer
Metastasis
Eligibility:
MALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01168141
Start Date
July 1 2009
End Date
September 1 2010
Last Update
July 23 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The Christie NHS Foundation Trust
Manchester, United Kingdom