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Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00516438
Recruitment Status : Completed
First Posted : August 15, 2007
Last Update Posted : December 8, 2010
KuDOS Pharmaceuticals Limited
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Malignant Solid Tumors Drug: KU-0059436 (AZD2281)(PARP inhibitor) Drug: Topotecan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Topotecan + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Other Name: Olaparib

Drug: Topotecan
intravenous infusion
Other Names:
  • Hycamtin®
  • Topotecan hydrochloride

Primary Outcome Measures :
  1. To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan [ Time Frame: assessed at each visit ]

Secondary Outcome Measures :
  1. To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histological or cytological diagnosis of advanced solid tumour for which no suitable effective therapy exists;
  • Evaluable disease
  • Adequate bone marrow, hepatic and renal function

Exclusion Criteria:

  • Any chemotherapy, radiotherapy ( except palliative), endocrine or immunotherapy within 4 weeks prior to entry; major surgery with 4 weeks of entering the study
  • Heavily pre treated patient > 2 previous chemotherapy regimens for metastatic disease
  • Co-existing active infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00516438

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United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Leicester, United Kingdom
Research Site
Manchester, United Kingdom
Sponsors and Collaborators
KuDOS Pharmaceuticals Limited
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Principal Investigator: James Cassidy Beaston Oncology Centre, Glasgow, UK
Study Director: James Carmichael, BSc MBChB MD FRCP KuDOS Pharmaceutical Ltd

Layout table for additonal information Identifier: NCT00516438     History of Changes
Other Study ID Numbers: KU36-93
First Posted: August 15, 2007    Key Record Dates
Last Update Posted: December 8, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
malignant solid tumours
Poly(ADP ribose)

Additional relevant MeSH terms:
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Poly(ADP-ribose) Polymerase Inhibitors
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents