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.
Sponsor:
Collaborator:
KuDOS Pharmaceuticals Limited
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00633269
First received: March 5, 2008
Last updated: January 13, 2009
Last verified: January 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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:
    Drug: AZD2281
    100mg Oral Dose
    Other Name: Olaparib
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014