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Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer

NCT00628251 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-12-05

Study results available
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Summary

The purpose of the study is to compare the efficacy and safety of 2 doses of drug AZD2281 against liposomal doxorubicin to see which is effective and well tolerated in treating patients with measurable BRCA1- or BRCA2-positive advanced ovarian cancer and who have failed previous platinum therapy.

Conditions

  • Ovarian Neoplasms

Interventions

DRUG

AZD2281

400mg Oral twice daily

DRUG

Liposomal Doxorubicin

50mg/m2 Monthly Intravenous

DRUG

AZD2281

200mg oral twice daily

Sponsors & Collaborators

Principal Investigators

  • Jane Robertson, BSc, MBCHB, MD · AstraZeneca

  • Stan Kaye, BSc, MB, FRCP, FRCR, SMedSCi · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-07-30
Primary Completion
2009-09-15
Completion
2018-09-19

Countries

  • United States
  • Australia
  • Belgium
  • Germany
  • Israel
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT00628251 on ClinicalTrials.gov