Table 3.
Table. | Patients | Phase | N | Arms/Treatments |
---|---|---|---|---|
GOG283 [31] | Recurrent | II | 35 | Dasatinib 140 mg/day |
NiCCC (ENGOT-GYN1) [32] |
Recurrent | II (Randomized) | 120 | SoC Nintedanib 400 mg/day |
NRG-GY-014 [33] | Recurrent | II (basket) | 86 | Tazemetostat |
NRG-GY-016 [34] | Recurrent | II | 14 | Pembrolizumab + Epacadostat |
ATARI [35] | Recurrent | II | 40<, <116 | Ceralasertib 160 mg +/− Olaparib 600mg/day * |
Abbreviations: SoC, Standerd of care[ Ovarian Cancer Patients: Paclitaxel (80 mg/m2) IV Day 1, 8, 15 every 28 days Pegylated Liposomal Doxorubicin (PLD) (40 mg/m2) IV every 28 days Topotecan (4 mg/m2) IV Day 1, 8, 15 every 28 days,Endometrial Cancer Patients: Carboplatin (AUC 5) and Paclitaxel (175 mg/m2) IV every 21 days Doxorubicin IV (60 mg/m2) every 21 days]; * Cohort 1A patients receive ceralasertib monotherapy (160 mg tablets twice daily on days 1–14 in a 28 day cycle). If no activity is observed in this cohort, cohort 1B will open, with the same patient population receiving ceralasertib plus olaparib in combination (160 mg ceralasertib tablets once daily on days 1–7 and 300 mg olaparib tablets twice daily continuously in a 28 day cycle). Patients with clear cell carcinomas (ovarian, endometrial, or endometriosis related) with no ARID1A loss enter cohort 2 and patients with other relapsed gynecological subtypes enter cohort 3, irrespective of ARID1A status. Both cohort 2 and cohort 3 patients receive combination therapy (160 mg ceralasertib tablets once daily on days 1–7 and 300 mg olaparib tablets twice daily continuously in a 28 day cycle).