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Sponsors and Collaborators: |
AstraZeneca KuDOS Pharmaceuticals Limited |
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Information provided by: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00516438 |
The purpose of this study is to identify a safe and tolerable dose of the drug KU-0059436 that can be given in combination with topotecan chemotherapy in patients with advanced solid tumours
Condition | Intervention | Phase |
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Malignant Solid Tumors |
Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Topotecan |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
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 |
Estimated Enrollment: | 48 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Topotecan + KU-0059436
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Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Drug: Topotecan
intravenous infusion
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United Kingdom | |
Research Site | |
Glasgow, United Kingdom | |
Research Site | |
Leicester, United Kingdom | |
Research Site | |
Manchester, United Kingdom |
Principal Investigator: | James Cassidy | Beaston Oncology Centre, Glasgow, UK |
Study Director: | James Carmichael, BSc MBChB MD FRCP | KuDOS Pharmaceutical Ltd |
Study ID Numbers: | KU36-93, D0810C00006 |
Study First Received: | August 13, 2007 |
Last Updated: | January 13, 2009 |
ClinicalTrials.gov Identifier: | NCT00516438 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
malignant solid tumours Poly(ADP ribose) polymerases |
Topotecan |
Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |