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

Phase 1

Completed

• Conditions: Neoplasm Metastasis

• Registration Number: NCT00633269
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-03-05
• Study First Submitted QC: 2008-03-05
• Study First Posted: 2008-03-12
• Study Start: 2008-04
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2009-01
• Last Update Submitted: 2009-01-13
• Last Update Posted: 2009-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Histologically confirmed advanced or metastatic tumour, refractory to standard therapies

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	Various timepoints

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Research Site; 🇬🇧 London, United Kingdom