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

Study identifier:D0810C00020

ClinicalTrials.gov identifier:NCT00679783

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Phase II, Open Label, Non-Randomized Study of AZD2281 in the Treatment of Patients with Known BRCA or Recurrent High Grade Serous/ Undifferentiated Tubo-Ovarian Carcinoma and in Known BRCA or Triple Negative Breast Cancer to Determine Response Rate and Correlative Markers of Response

Medical condition

Ovarian Carcinoma

Phase

Phase 2

Healthy volunteers

No

Study drug

AZD2281

Sex

All

Actual Enrollment

99

Study type

Interventional

Age

18 Years - 130 Years

Date

Study Start Date: 08 Jul 2008
Primary Completion Date: 26 Mar 2010
Study Completion Date: 20 Jul 2022

Study design

Allocation: Non-randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2023 by AstraZeneca

Sponsors

AstraZeneca

Collaborators

British Columbia Cancer Agency

Inclusion and exclusion criteria