Open label, dose escalation Phase I study of AZD2281

Study identifier:D0810C00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, open-label, dose escalation study to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies

Medical condition

Advanced solid malignancies

Phase

Phase 1

Healthy volunteers

No

Study drug

KU-0059436 (AZD2281)(PARP inhibitor)

Sex

All

Actual Enrollment

18

Study type

Interventional

Age

20 Years - 74 Years

Date

Study Start Date: 01 Nov 2007
Primary Completion Date: 01 Mar 2009
Study Completion Date: 01 Jun 2009

Study design

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

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria