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Phase II Study of AZD2281 in Patients With Known BRCA Mutation Status or Recurrent High Grade Ovarian Cancer or Patients With Known BRCA Mutation Status/ Triple Neg Breast Cancer

NCT00679783 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-07-12

Study results available
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Summary

This is a Phase II, open label, non randomized correlative study of AZD2281 in patients with recurrent breast and ovarian cancer in both BRCA inherited mutation carriers and non-carriers to identify objective response rate and to assess for early markers of activity and to assess correlative markers that may provide helpful information for subsequent clinical trials. Approximately 110 patients from 7 centers in Canada will be enrolled into this study

Conditions

Interventions

DRUG

AZD2281

PARP inhibitor Olaparib tablets, oral

Sponsors & Collaborators

  • British Columbia Cancer Agency

    collaborator OTHER

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Karen Gelmon, MD · British Columbia Cancer Agency

  • Jane Robertson, BSc, MBCHB, MD · AstraZeneca

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-08
Primary Completion
2010-03-26
Completion
2022-07-20

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
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 NCT00679783 on ClinicalTrials.gov