MedTrace Logo

Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer

NCT00494234 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-01-19

Study results available
· View outcomes & findings →

Summary

The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Olaparib

Participants will receive capsules of olaparib orally as stated in arm description.

Sponsors & Collaborators

  • KuDOS Pharmaceuticals Limited

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • James Carmichael, BSc, MBChB, MD, FRCP · KuDOS Pharmaceuticals Limited

  • Andrew Tutt, PhD MRCP FRCR · Guy's and St Thomas's NHS Foundation Trust, London, UK

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-15
Primary Completion
2009-02-27
Completion
2022-12-21

Countries

  • United States
  • Australia
  • Canada
  • Germany
  • Israel
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00494234 on ClinicalTrials.gov