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. 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 Assessment of Efficacy of AZD2281 in Platinum Sensitive Serous Ovarian Cancer
Methods Phase II Randomised, Double Blind, Multicenter Study
Participants Women with platinum-sensitive serous ovarian tumours following treatment with two or more platinum-containing regimens
Interventions Randomisation to AZD2281 or placebo
Outcomes Primary:
  • Efficacity measured by Progression-free survival (PFS)


Secondary:
  • Overall survival (OS)

  • Best overall response (ORR)

  • Duration of response

  • Cancer antigen (CA)-125 response measured every 28 days

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

  • Safety assessments every 28 days: adverse events (AEs), physical examination, vital signs including blood pressure (BP), pulse, electrocardiogram (ECG) and laboratory findings including clinical chemistry, haematology and urinalysis.

Starting date August 2008
Contact information Information.Center@astrazeneca.com
Notes http://clinicaltrials.gov/show/NCT00753545