Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours

This study has been completed.

First Received: March 5, 2008 Last Updated: January 13, 2009 History of Changes

Sponsors and Collaborators:	AstraZeneca KuDOS Pharmaceuticals Limited
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00633269

Purpose

Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.

Condition	Intervention	Phase
Neoplasm Metastasis	Drug: AZD2281	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study
Official Title:	Open, Non-Randomized, Single Centre Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of a Single Oral 100 mg Dose of [14C]-AZD2281 (KU-0059436) in Patients With Advanced or Metastatic Solid Tumours Refractory to Standard Treatments

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Ribose AZD 2281

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours, assessed by blood, urine and faecal sampling [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs. [ Designated as safety issue: Yes ]
To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites [ Designated as safety issue: No ]
To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints. [ Designated as safety issue: No ]

Estimated Enrollment:	6
Study Start Date:	April 2008
Study Completion Date:	October 2008
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Intervention Details:

100mg Oral Dose

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed advanced or metastatic tumour, refractory to standard therapies

Exclusion Criteria:

Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative radiotherapy), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to study entry.
Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study.
Females will be able to continue to take hormone replacement therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00633269

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

KuDOS Pharmaceuticals Limited

Investigators

Study Director:	James Carmichael, BSc, MBChB, MD, FRCP	KuDOS Pharmaceuticals, Ltd
Principal Investigator:	Johann deBono, MD, FRCP, MSc PhD	Royal Marsden Hospital, Surrey, UK

More Information

No publications provided

Responsible Party:	AstraZeneca ( Jim Carmichael - CMO )
Study ID Numbers:	D0810C00010, KU36-37
Study First Received:	March 5, 2008
Last Updated:	January 13, 2009
ClinicalTrials.gov Identifier:	NCT00633269 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by AstraZeneca:

Poly(ADP ribose) polymerases
Metastatic Solid Tumours

Study placed in the following topic categories:

Neoplasm Metastasis

Additional relevant MeSH terms:

Neoplasms
Neoplastic Processes
Pathologic Processes
Neoplasm Metastasis

ClinicalTrials.gov processed this record on September 10, 2009