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Completed

NCT Number: NCT00633269

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

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.

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Key information

Conditions

Neoplasm Metastasis Neoplasms Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

London, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD2281

Drug

100mg Oral Dose

Other names: Olaparib

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • KuDOS Pharmaceuticals Limited

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2008
Registry last updated
Jan 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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