Skip to main content

Table 3 Overview of PARP inhibitor trials in EOC Treatment

From: Maintenance therapy for recurrent epithelial ovarian cancer: current therapies and future perspectives – a review

Trial name [ClinicalTrials.gov identifier]s PARPi (approval status) Mono/Combo; Phase; PARP enzyme targeted Patient population and key eligibility N Treatment arms Primary endpoint Results/Trial status
Study 42 (NCT01078662) [56] Olaparib (approved) Mono;
PARP 1 > PARP2> > PARP3
Confirmed genetic BRCA1 and/or BRCA2 mutation 298 Olaparib 400 mg (8 × 50 mg capsules), oral BID until progression of the disease Tumor response rate ORR was 34% (46/137; 95% CI: 26–42) and median DoR was 7.9 (95% CI 5.6–9.6) months
LIGHT study (NCT02983799) [57] Olaparib (approved) PARP 1 > PARP2> > PARP3 gBRCAm and wt PSROC HGS 260 Olaparib 300 mg after ≥1 L PBC ORR Ongoing; study completion 2020
SOLO3/ NCT02282020 [11] Olaparib (approved) Mono; Phase III; PARP 1 > PARP2> > PARP3 gBRCAm PSROC 411 Olaparib vs. physician’s choice of single agent standard of care non-platinum based chemotherapy (TPC) after ≥2 L PBC ORR ORR 72% olaparib vs 51% TPC OR 2.53 (1.40, 4.58)
p = 0.002
PFS 13.4 vs 9.2 mo
HR 0.62 (0.43, 0.91);
P = 0.013
NCT01081951 Olaparib (approved) Combo; Phase II; PARP 1 > PARP2> > PARP3 PSROC (both germline BRCA and sporadic) 162 200 or 400 mg BID olaparib + C + Pac vs C + Pac as first line PFS Prelim results: Median PFS 12.2 (olaparib arm) versus 9.6 mos (no olaparib) p = 0.0012; study completion Dec 2018
NRG-GY005 (NCT0250226) Olaparib (approved) Combo; Phase II/III; PARP 1 > PARP2> > PARP3 Platinum resistant recurrent high-grade
OC
680 Olaparib/cediranib versus single agent chemotherapy PFS (phase II)
OS (phase III)
Ongoing; study completion 2023
NCI-OVM1403/NRG-GY004 (NCT0244660) Olaparib (approved) Combo; Phase III; PARP 1 > PARP2> > PARP3 PSROC HGS; BRCA stratified 549 Olaparib versus olaparib/cediranib versus platinum doublet PFS Ongoing; study completion Dec 2019
ENGOTOV24/AVANOVA (NCT02354131) Niraparib (investigational; approved only for maintenance) Combo; Phase I/II; PARP1 and PARP2 PSROC 108 Niraparib versus niraparib-bevacizumab PFS Ongoing; study completion 2020
ARIEL 2 (Part 1: results available; Part 2 ongoing) (NCT01891344) [53] Rucaparib (approved) PARP 1>>>> > PARP2 PSROC HGS 493 600 mg BID rucaparib PFS Prelim results: PFS in the BRCAm (HR 0.27, 95% CI 0.16–0.44, p < 0.0001) LOH high (0.62, 0.42–0.90, p = 0.011)
ARIEL4/NCT02855944 Rucaparib (approved) Mono; Phase III; PARP 1>>>> > PARP2 BRCAm HGSOC (platinum sensitive and resistant) 345 Rucaparib vs PBC PFS Ongoing; study completion 2024
NCT01113957 Veliparib (investigational) Combo; PARP 1 and PARP2 Recurrent HGSOC (both germline BRCA and sporadic allowed) 168 [1] Veliparib and temozolomide vs.
[2] PLD
ORR Results not available
NCT01306032 [58] Veliparib (investigational) Combo; PARP 1 and PARP2 Recurrent HGSOC (both germline BRCA and sporadic allowed) 75 Oral cyclophos 50 mg + veliparib 60 mg daily vs. Oral cyclophos 50 mg daily ORR Well tolerated with some clinical activity; addition of veliparib at 60 mg daily did not improve either the response rate or the median PFS
  1. PARPi: Poly ADP-ribose polymerase inhibitor; PLD: pegylated liposomal doxorubicin; Cyclophos: cyclophosphamide; CI: confidence interval; DoR: duration of response; N: patient accural; wt: wild-type BRCA; gBRCAm: BRCA germline mutation carrier; BRCAm: BRCA mutant; PFS: progression free survival; ORR: overall response rate; HGSOC: high-grade serous ovarian cancer; PSROC: platinum sensitive recurrent ovarian cancer; HR: hazard ratio