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. 2015 May 20;2015(5):CD007929. doi: 10.1002/14651858.CD007929.pub3
Trial name or title A maintenance study with niraparib versus placebo in patients with platinum sensitive ovarian cancer
Methods Phase 3, multicentre, randomised, double‐blind, placebo‐controlled study
Participants Platinum‐sensitive ovarian cancer patients who have either gBRCAmut or a tumour with high‐grade serous histology and who have responded to their most recent chemotherapy containing a platinum agent
Interventions 2:1 ratio of niraparib versus placebo Administered once daily continuously during a 28‐day cycle
Outcomes Progression‐free survival
overall survival
Quality of life
Safety and tolerability
Starting date June 2013
Contact information Shefali Agarwal; Sagarwal@tesarobio.com
Notes Estimated completion date October 2016. Last updated 23 Feb 2015. Last accessed 7 April 2015.