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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014