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

NCT ID: NCT00516438

Last Updated: 2010-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2009-11-30

Brief Summary

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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

Detailed Description

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Conditions

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Malignant Solid Tumors

Keywords

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malignant solid tumours Poly(ADP ribose) polymerases

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Topotecan + KU-0059436

Group Type EXPERIMENTAL

KU-0059436 (AZD2281)(PARP inhibitor)

Intervention Type DRUG

oral

Topotecan

Intervention Type DRUG

intravenous infusion

Interventions

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KU-0059436 (AZD2281)(PARP inhibitor)

oral

Intervention Type DRUG

Topotecan

intravenous infusion

Intervention Type DRUG

Other Intervention Names

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Olaparib Hycamtin® Topotecan hydrochloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KuDOS Pharmaceuticals Limited

INDUSTRY

Sponsor Role collaborator

AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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James Cassidy

Role: PRINCIPAL_INVESTIGATOR

Beaston Oncology Centre, Glasgow, UK

James Carmichael, BSc MBChB MD FRCP

Role: STUDY_DIRECTOR

KuDOS Pharmaceutical Ltd

Locations

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Research Site

Glasgow, , United Kingdom

Site Status

Research Site

Leicester, , United Kingdom

Site Status

Research Site

Manchester, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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D0810C00006

Identifier Type: -

Identifier Source: secondary_id

KU36-93

Identifier Type: -

Identifier Source: org_study_id