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

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ClinicalTrials.gov Identifier: NCT00633269
Recruitment Status : Completed
First Posted : March 12, 2008
Last Update Posted : January 14, 2009
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Neoplasm Metastasis Drug: AZD2281 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Olaparib
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: AZD2281
    100mg Oral Dose
    Other Name: Olaparib

Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Jim Carmichael - CMO, AstraZeneca
ClinicalTrials.gov Identifier: NCT00633269     History of Changes
Other Study ID Numbers: D0810C00010
KU36-37
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: January 14, 2009
Last Verified: January 2009

Keywords provided by AstraZeneca:
Poly(ADP ribose) polymerases
Metastatic Solid Tumours

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Olaparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents