Study assessing metabolism, excretion and pharmacokinetics of a Poly (ADP-ribose) polymerase (PARP) inhibitor in patients with solid metastatic tumours

Study identifier:D0810C00010

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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

Medical condition

Neoplasm Metastasis

Phase

Phase 1

Healthy volunteers

No

Study drug

AZD2281

Sex

All

Actual Enrollment

6

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2008
Primary Completion Date: 01 Oct 2008
Study Completion Date: 01 Oct 2008

Study design

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

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

KuDOS Pharmaceuticals Ltd (a member of the AstraZeneca Group of companies)

Inclusion and exclusion criteria