A study to assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)
Study identifier:KU36-92
ClinicalTrials.gov identifier:NCT00516373
EudraCT identifier:2005-001435-29
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients with Advanced Tumours.
Medical condition
ovarian neoplasms
Phase
Phase 1
Healthy volunteers
No
Study drug
KU-0059436 (AZD2281)(PARP inhibitor)
Sex
All
Actual Enrollment
98
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 11 Jul 2005
Primary Completion Date: 17 Dec 2008
Study Completion Date: 26 Apr 2023
Study design
Allocation: Non-randomized
Endpoint Classification: Safety
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Feb 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: KU-0059436 KU-0059436 administered orally twice daily | Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Name: Olaparib |
Contacts
Investigators
Principal Investigator
Jane Robertson
AstraZeneca
