Trial name [ClinicalTrials. gov identifier] | Drug (approval status) | Mono/Combo; Phase; PARP enzymes targeted | Patient population; newly diagnosed/recurrent and key eligibility | N | Treatment arms | Primary endpoint | Results/Trial status |
---|---|---|---|---|---|---|---|
SOLO-2 (NCT01874353) [51] | Olaparib (approved) | Mono; Phase III; PARP 1 > PARP2> > PARP3 | PSROC HSG; ≥2 PBC BRCAm only, gBRCAmut BRCA1: Ola:132 (67%) PBO: 61 (62%) BRCA2: Ola: 58 (30%) PBO: 35 (35%) | 295 | Olaparib 300 mg bid vs placebo maintenance after ≥2 PBC | PFS | Ola vs PBO: 19.3 months (95% CI 16.5–27.3) vs 5.5 months (5.0–5.8); HR [in favor of ola] 0.33, 95% CI 0.24–0.44; p < 0.0001).; study completion 2021 |
Olaparib (approved) | Mono; Phase III; PARP 1 > PARP2> > PARP3 | Germline BRCA mutant only, newly diagnosed HGSOC or endometrioid stage III and IV Of 391 patients at interim analysis, centrally confirmed gBRCA1/2 m: 388 somatic BRCA1/2 m: 2 | 451 | Olaparib 300 mg bid vs placebo maintenance after 1 L PBC | PFS | Primary analysis: 60% vs. 27% in ola vs PBO (HR for disease progression or death, 0.30; 95% CI, 0.23 to 0.41; p < 0.001) Ongoing; study completion 2023 | |
PAOLA1/ENGOT/GCIG (NCT02477644) [66] | Olaparib (approved) | Combo; Phase III; PARP 1 > PARP2> > PARP3 | Newly diagnosed HGSOC | 612 | Bev or bev/olaparib maintenance after 1 L platinum/taxane/bev | PFS | Ongoing; study completion 2022 |
ICON 9 trial (NCT03278717) | Olaparib (approved) | Combo; Phase III; PARP 1 > PARP2> > PARP3 | PSROC | 618 | Olaparib or olaparib/cediranib maintenance after 1 L PBC | PFS and OS | Ongoing; study completion 2023 |
ENGOT-OV26/PRIMA (NCT02655016) [67] | Niraparib (approved) | Mono; Phase III; PARP1 and PARP2 | HRD positive, stage III and IV | 305 | Niraparib vs placebo maintenance after 1 L PBC with PR or CR | PFS | Ongoing; study completion August 2019 |
GOG-3005 (NCT02470585) [11] | Velaparib (investigational) | Combo; Phase III; PARP 1and PARP2 | Advanced HGSOC, both BRCA germline mutation carriers and BRCA wild types | 1140 | Veliparib vs placebo maintenance after 1 L (C + Pac) or (C + Pac + veliparib) | PFS | Ongoing; study completion 2020 |