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OpenTrials
Completed

NCT Number: NCT00516438

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

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

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Key information

Conditions

Malignant Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Glasgow, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

KU-0059436 (AZD2281)(PARP inhibitor)

Drug

oral

Other names: Olaparib

Topotecan

Drug

intravenous infusion

Other names: Hycamtin®, Topotecan hydrochloride

Primary outcomes

  1. To establish the maximum tolerated dose (MTD) of KU 0059436 in combination with topotecan

    Time frame: assessed at each visit

Secondary outcomes

  1. To identify the dose limiting toxicity of the combination therapy

    Time frame: assessed at each visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • KuDOS Pharmaceuticals Limited

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 15, 2007
Registry last updated
Dec 8, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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