Skip to main content
. Author manuscript; available in PMC: 2014 Sep 22.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jun 16;(6):CD007929. doi: 10.1002/14651858.CD007929.pub2
Trial name or title Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Liposomal Doxorubicin in BRCA positive Advanced Ovarian Cancer (ICEBERG 3)
Methods Phase II, Randomised,Open-Label, Comparative, International Multicenter Study
Participants
  • Advanced ovarian cancer with positive BRCA1 or BRCA2 status

  • Progressive or recurrent disease after platinum-based chemotherapy

Interventions Experimental arm:
AZD2281 given at 400 mg twice daily
AZD2281 given at 200 mg twice daily
Active comparator arm:
Liposomal Doxorubicin (LPD) 50mg/m2 intravenously every 4 weeks
Outcomes Primary
  • Efficacity measured by Progression-free survival (PFS)

  • Best overall response (ORR)

  • Duration of response

  • Cancer antigen (CA)-125 response measured every 4 weeks

  • Radiological tumour assessments will be performed every 12 weeks for 1st 60 weeks and then every 24 weeks


Secondary
  • Comparison of safety and tolerability

Starting date July 2008
Contact information Information.Center@astrazeneca.com
Notes http://clinicaltrials.gov/show/NCT00628251