A Study to Assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

This study is ongoing, but not recruiting participants.

First Received: August 13, 2007 Last Updated: January 20, 2010 History of Changes

Sponsor:	AstraZeneca
Collaborator:	KuDOS Pharmaceuticals Limited
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00516373

Purpose

To determine the safety, tolerability, dose-limiting toxicity (DLT), pharmacokinetic-pharmacodynamic profile, and maximum tolerated dose (MTD) of KU-0059436 when administered orally to patients with advanced solid tumours. To further evaluate the safety and efficacy of KU-0059436 in an expanded cohort of BCRA-enriched population, primarily ovarian cancer patients.

Condition	Intervention	Phase
Ovarian Neoplasms BRCA1 Protein BRCA2 Protein	Drug: KU-0059436 (AZD2281)(PARP inhibitor)	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients With Advanced Tumours.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Ribose AZD 2281

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436 [ Time Frame: assessed at each visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Objective tumour response [ Time Frame: assessed every 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2010
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00516373

Locations

Belgium
Research Site
Brussels, Belgium
Netherlands
Research Site
Amsterdam, Netherlands
Poland
Research Site
Szczecin, Poland
United Kingdom
Research Site
London, United Kingdom
Research Site
Edinburgh, United Kingdom

Sponsors and Collaborators

AstraZeneca

KuDOS Pharmaceuticals Limited

Investigators

Study Director:	Prof James Carmichael, BSc MBChB MD FRCP	KuDOS Pharmaceuticals Ltd
Principal Investigator:	Dr. Johann De Bono, PhD MRCP FRCR	Royal Marsden Hospital Trust, London, UK

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Fong PC, Boss DS, Yap TA, Tutt A, Wu P, Mergui-Roelvink M, Mortimer P, Swaisland H, Lau A, O'Connor MJ, Ashworth A, Carmichael J, Kaye SB, Schellens JH, de Bono JS. Inhibition of poly(ADP-ribose) polymerase in tumors from BRCA mutation carriers. N Engl J Med. 2009 Jul 9;361(2):123-34. Epub 2009 Jun 24.

Study ID Numbers:	D0810C00002, KU36-92
Study First Received:	August 13, 2007
Last Updated:	January 20, 2010
ClinicalTrials.gov Identifier:	NCT00516373 History of Changes
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); United Kingdom: Medicines and Healthcare Products Regulatory Agency; Belgium: Federal Agency for Medicinal Products and Health Products; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; United States: Food and Drug Administration

Keywords provided by AstraZeneca:

advanced ovarian cancer
BRCA 1 protein
BRCA 2 protein
Poly(ADP ribose)polymerases

Additional relevant MeSH terms:

Genital Diseases, Female
Neoplasms
Neoplasms by Site
Ovarian Neoplasms
Gonadal Disorders
Genital Neoplasms, Female

Endocrine System Diseases
Urogenital Neoplasms
Ovarian Diseases
Adnexal Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on February 08, 2010