Table 1.

Important previous and ongoing phase II/III studies of PARPis in EOC

SettingStudy identifierAgentsDesignPatients/accrualPrimary endpointResults/status
First-line/maintenanceNCT01844986Olaparib vs. placeboPhase III, randomized, double-blind, placebo controlledBRCAm high-grade serous or high-grade endometrioid ovarian cancerPFSOngoing
N = 397
Recurrent/maintenanceNCT00753545Olaparib vs. placeboPhase II, randomized, double-blind, placebo controlledRecurrent platinum-sensitive high-grade serous
N = 265
PFSBRCAm PFS: 11.2 vs. 4.3 months; HR, 0.18
Non-BRCAm PFS: 7.4 vs. 5.5 months; HR, 0.54
Recurrent/maintenanceNCT01847274Niraparib vs. placeboPhase III, randomized, double-blind, placebo controlledPlatinum-sensitive recurrent high-grade serous endometrioid/BRCA stratifiedPFSOngoing
N = 490
Recurrent/maintenanceNCT01874353Olaparib vs. placeboPhase III, randomized, double-blind, placebo controlledRecurrent platinum-sensitive BRCAm high-grade serous or endometrioid EOCPFSOngoing
N = 297
Recurrent/maintenanceNCT01968213Rucaparib vs. placeboPhase III, randomized, double-blind, placebo controlledPlatinum-sensitive recurrent high-grade serous endometrioid/BRCA stratifiedPFSOngoing
N = 540
Recurrent/maintenanceNCT01081951Olaparib/Carbo/Taxol vs. Carbo/TaxolRandomized phase II, open-labelPlatinum-sensitive recurrent HGSOC (both BRCAm and non-BRCAm)PFSALL: 12.2 vs. 9.6 months; HR, 0.51
BRCAm: HR, 0.21
N = 173
RecurrentNCT01116648Olaparib/cediraniib vs. olaparibRandomized phase II, open-labelPlatinum-sensitive recurrent HGSOC (both BRCAm and non-BRCAm)PFSALL: 17·7 vs. 9.0 months; HR, 0.42
BRCAm: 19.4 vs. 16.5 months; HR, 0.55
non-BRCAm: 16.5 vs. 5.7 months; HR, 0.32
N = 90

NOTE: ALL refers to all patients in the study, both BRCA-mutated and non–BRCA-mutated.

Abbreviation: BRCAm, BRCA-mutated.