Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Topotecan - Full Text View

Sponsors and Collaborators:	AstraZeneca KuDOS Pharmaceuticals Limited
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00516438

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 I

MedlinePlus related topics: Cancer

Drug Information available for: Topotecan hydrochloride Topotecan Ribose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

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
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Topotecan + KU-0059436	Drug: KU-0059436 (AZD2281)(PARP inhibitor) oral Drug: Topotecan intravenous infusion

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

Study ID Numbers:	KU36-93, D0810C00006
Study First Received:	August 13, 2007
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00516438
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

malignant solid tumours
Poly(ADP ribose)
polymerases

Study placed in the following topic categories:

Topotecan

Additional relevant MeSH terms:

Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009