Study to assess the safety and tolerability of a PARP inhibitor in combination with topotecan
Study identifier:KU36-93
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients with Advanced Solid Tumours
Medical condition
Malignant solid tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
KU-0059436 (AZD2281)(PARP inhibitor), Topotecan
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jul 2007
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Nov 2009
Study design
Allocation: Non-randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
KuDOS Pharmaceuticals Ltd(a member of the AstraZeneca group of companies)
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Topotecan + KU-0059436 | Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Other Name: Olaparib Drug: Topotecan intravenous infusion Other Name: Hycamtin® Other Name: Topotecan hydrochloride |
Contacts
Investigators
Principal Investigator
James Cassidy
Beaston Oncology Centre, Glasgow, UK
