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

This study has been completed.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00516438
First received: August 13, 2007
Last updated: December 7, 2010
Last verified: December 2010
  Purpose

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
Malignant Solid Tumors
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
Drug: Topotecan
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To identify the dose limiting toxicity of the combination therapy [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: July 2007
Study Completion Date: November 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Topotecan + KU-0059436
Drug: KU-0059436 (AZD2281)(PARP inhibitor)
oral
Other Name: Olaparib
Drug: Topotecan
intravenous infusion
Other Names:
  • Hycamtin®
  • Topotecan hydrochloride

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516438

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

No publications provided

ClinicalTrials.gov Identifier: NCT00516438     History of Changes
Other Study ID Numbers: KU36-93, D0810C00006
Study First Received: August 13, 2007
Last Updated: December 7, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Neoplasms
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014