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

Primary Purpose

Neoplasm Metastasis

Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
AZD2281
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasm Metastasis focused on measuring Poly(ADP ribose) polymerases, Metastatic Solid Tumours

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site

Outcomes

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

Secondary Outcome Measures

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.

Full Information

First Posted
March 5, 2008
Last Updated
January 13, 2009
Sponsor
AstraZeneca
Collaborators
KuDOS Pharmaceuticals Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00633269
Brief Title
Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca
Collaborators
KuDOS Pharmaceuticals Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm Metastasis
Keywords
Poly(ADP ribose) polymerases, Metastatic Solid Tumours

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
AZD2281
Other Intervention Name(s)
Olaparib
Intervention Description
100mg Oral Dose
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs.
Title
To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites
Title
To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Carmichael, BSc, MBChB, MD, FRCP
Organizational Affiliation
KuDOS Pharmaceuticals, Ltd
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johann deBono, MD, FRCP, MSc PhD
Organizational Affiliation
Royal Marsden Hospital, Surrey, UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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