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Study to Assess the Efficacy and Safety of a PARP Inhibitor for the Treatment of BRCA-Positive Advanced Ovarian Cancer

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Closed

18 and over

Pharmaceutical / Industry

KU36-58
D0810C00009, NCT00494442

Trial Description

Summary

The purpose of the study is to see if the drug KU 0059436 is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and for whom no curative therapeutic option exists.

Eligibility Criteria

Inclusion Criteria:

Advanced ovarian cancer with positive BRCA1 or BRCA2 status

Failed at least one prior chemotherapy

In investigators opinion, no curative standard therapy exists

Measurable disease

Exclusion Criteria:

Brain metastases

Less than 28 days since last treatment used to treat the disease

Considered a poor medical risk due to a serious uncontrolled disorder

Trial Contact Information

Trial Lead Organizations/Sponsors

AstraZeneca Pharmaceuticals LP

Kudos Pharmaceuticals

James Carmichael, BSc MBChB MD FRCP

Study Director

Andrew Tutt, PhD MRCP FRCR

Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00494442
Information obtained from ClinicalTrials.gov on October 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.