Table 2.
Study | Phase | Population | Study Arm | Control Arm | Results |
---|---|---|---|---|---|
Study-19 NCT00753545 |
II | Recurrent HG (G2 or 3) OC/FP/PPC ≥2 platinum-based chemotherapy With an objective response to the platinum regimen |
Olaparib 400 mg BID | Placebo | gBRCAm PFS 11.2 vs. 4.3 m HR 0.18 (95% CI, 0.10–0.31) |
SOLO-2 NCT01874353 |
III | Recurrent OC/FP/PPC ≥2 platinum-based chemotherapy With an objective response to the platinum regimen BRCAm |
Olaparib 300 mg BID | Placebo | PFS 19.1 vs. 5.5 m HR 0.30 (95% CI, 0.22–0.41) |
NOVA NCT01847274 |
III | Recurrent HGSOC/FP/PPC ≥2 platinum-based chemotherapy Platinum sensitive (>6 months) |
Niraparib 300 mg daily | Placebo | gBRCAm PFS: 21.0 vs. 5.5 m HR 0.27 (95% CI, 0.17–0.41) Non-gBRCA PFS 9.3 vs. 3.9 m HR 0.45 (95% CI, 0.34–0.61) |
ARIEL-3 NCT01968213 |
III | Recurrent HGSOC/endometrioid (or FP/PPC) ≥2 platinum-based chemotherapy Platinum sensitive (>6 months) ≤1 non-platinum chemotherapy CR/PR platinum-based chemotherapy |
Rucaparib 600 mg BID | Placebo | ITT PFS 10.8 m vs. 5.4 m HR 0.37 (95% CI, 0.30–0.45) BRCAm PFS 16.6 m vs. 5.4 m HR 0.23 (95% CI, 0.16–0.34) |