Study to assess the safety and tolerability of a PARP inhibitor in combination with topotecan

Study identifier:KU36-93

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Phase I, Open-Label, Study of the Safety and Tolerability of KU-0059436 and Topotecan in the Treatment of Patients with Advanced Solid Tumours

Medical condition

Malignant solid tumors

Phase

Phase 1

Healthy volunteers

No

Study drug

KU-0059436 (AZD2281)(PARP inhibitor), Topotecan

Sex

All

Actual Enrollment

48

Study type

Interventional

Age

18 Years +

Date

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

Study design

Allocation: Non-randomized
Endpoint Classification: Safety 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