SOLO2/ENGOT-Ov21 , trial summary

A randomised clinical trial investigating the effect of olaparib versus placebo in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation

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NCT01874353    Lancet Oncol 2017;:  



Studied treatment olaparib 300 mg in two 150 mg tablets, twice daily
Control treatment placebo



Patients patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation
Group sizes196 / 99



Blindness double-blind Inclusion period 2013 sept - 201' nov
Follow-up duration Centers multicentre
Lost to FU geographical localisation international
Primary endpoint investigator-assessed progression-free survival Design
PeriodeInclusion2013 sept - 201' nov



EndpointX1N1X0N0TE95% CI OS - -9 - -9 no data ORR - -9 - -9 no data PFS - -9 - -9 0,30[0,22; 0,41]0,22,01,0

Pujade-Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, Korach J, Huzarski T, Poveda A, Pignata S, Friedlander M, Colombo N, Harter P, Fujiwara K, Ray-Coquard I, Banerjee S, Liu J, Lowe ES, Bloomfield R, Pautier P Olaparib tablets as maintenance therapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT-Ov21): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Oncol 2017;:     [PMID: 28754483]   link to pdf   add to Mendeley  

ClinicalTrial.gov record NCT01874353



Registering number NCT01874353 (see trial on clinicaltrials.gov)
Code Name