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

January 13, 2009 updated by: AstraZeneca

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

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.

Study Overview

Status

Completed

Conditions

Neoplasm Metastasis

Intervention / Treatment

Drug: AZD2281

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United Kingdom
- - London, United Kingdom
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	Various timepoints

Secondary Outcome Measures

Outcome Measure
To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs.
To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites
To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

March 5, 2008

First Submitted That Met QC Criteria