A study to assess the Safety and Pharmacokinetics of an Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP)

Study identifier:D0810C00002

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

A Phase I, Pharmacokinetic and Biological Evaluation of a Small Molecule Inhibitor of Poly ADP-Ribose Polymerase-1 (PARP-1), KU-0059436, in Patients with Advanced Tumours.

Medical condition

ovarian neoplasms

Phase

Phase 1

Healthy volunteers

No

Study drug

KU-0059436 (AZD2281)(PARP inhibitor)

Sex

All

Actual Enrollment

100

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jul 2005
Primary Completion Date: 01 Dec 2008
Estimated Study Completion Date: 01 Dec 2012

Study design

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

Verification:

Verified 01 Jan 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria