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

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

This study is currently recruiting participants.
Verified by AstraZeneca, September 2008

Sponsors and Collaborators:	AstraZeneca KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca group of companies)
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

ChemIDplus related topics:

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:	October 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

Contacts


Contact: AstraZeneca Clinical Information Center	1-800-236-9933	information.center@astrazeneca.com

Locations


United Kingdom
	Research Site	Recruiting
	Glasgow, United Kingdom
	Research Site	Recruiting
	Leicester, United Kingdom
	Research Site	Recruiting
	Manchester, United Kingdom

Sponsors and Collaborators

AstraZeneca

KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca group of companies)

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
First Received:	August 13, 2007
Last Updated:	September 4, 2008
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:

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Enzyme Inhibitors

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 07, 2008