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

Neoplasm Metastasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633269
• Other study ID #: D0810C00010
• Secondary ID: KU36-37
• Status: Completed
• Phase: Phase 1
• First received: March 5, 2008
• Last updated: January 13, 2009
• Start date: April 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm Metastasis

Intervention

Drug:
• AZD2281
100mg Oral Dose

Locations

Country	Name	City	State
United Kingdom	Research Site	London

Sponsors (2)

Lead Sponsor	Collaborator
AstraZeneca	KuDOS Pharmaceuticals Limited

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs.			Yes
Secondary	To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites			No
Secondary	To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints.			No