Status:
COMPLETED
Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
KuDOS Pharmaceuticals Limited
Conditions:
Neoplasm Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg \[14C\]-radiolabelled AZD2281 (KU-00594...
Eligibility Criteria
Inclusion
- Histologically confirmed advanced or metastatic tumour, refractory to standard therapies
Exclusion
- Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative radiotherapy), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to study entry.
- Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study.
- Females will be able to continue to take hormone replacement therapy
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00633269
Start Date
April 1 2008
End Date
October 1 2008
Last Update
January 14 2009
Active Locations (1)
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1
Research Site
London, United Kingdom