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. |