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 |