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

NCT00516373CompletedPHASE1INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

AstraZeneca

Enrollment

98

Start Date

2005-07-11

Completion Date

2008-12-17

Study Type

INTERVENTIONAL

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.

Interventions

KU-0059436 (AZD2281)(PARP inhibitor)

Conditions

Ovarian NeoplasmsBRCA1 ProteinBRCA2 Protein

Eligibility

Age Range

18 Years – 130 Years

Sex

ALL

Inclusion Criteria:

* Confirmed malignant advanced solid tumour refractory to standard therapy or for which no suitable effective standard therapy exists.

Exclusion Criteria:

* Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used).

Outcome Measures

Primary Outcomes

To determine the safety, tolerability, dose-limiting toxicity (DLT), and (MTD) of KU-0059436

Time frame: assessed at each visit

Secondary Outcomes

Objective tumour response

Time frame: assessed every 8 weeks

Locations

Research Site, Brussels, Belgium

Research Site, Amsterdam, Netherlands

Research Site, Szczecin, Poland

Research Site, Edinburgh, United Kingdom

Research Site, London, United Kingdom