Table 2.
Clinical trials with PARP inhibitors.
| PARPi | Clinical Trial Phase | Cancer Type | Comments | Reference |
|---|---|---|---|---|
| Olaparib | I (NCT00516373) | Solid tumours with gBRCA mutations | First trial of Olaparib as a single agent | [76] |
| II (NCT00679783) | TNBC with gBRCA mutations and high-grade ovarian cancer | No response in breast cancer | [30] | |
| II (NCT00753545) | Platinum-sensitive relapsed serous ovarian cancer with gBRCA mutations | This trial helped the FDA to approve the first PARP inhibitor in 2014 | [78] | |
| III (NCT01874353; SOLO-2) | Platinum-sensitive relapsed ovarian cancer with BRCA mutations | This trial supported FDA approval | [79] | |
| III (NCT01844986; SOLO-1) | BRCA-mutated ovarian cancer after platinum-based chemotherapy | This trial supported FDA approval as first-line maintenance therapy in ovarian cancer in 2018 | [80] | |
| III (NCT02000622) | gBRCA-mutated breast cancer | This trial supported FDA approval | [81] | |
| III (NCT02184195; POLO) | BRCA-mutated pancreatic cancer | This trial supported FDA approval as first-line maintenance therapy in pancreatic cancer | [82] | |
| Rucaparib | I (not applicable) | Melanoma and solid tumours | First trial in combination with temozolomide | [83] |
| I/II (NCT01482715; Study 10) | Solid tumours and BRCA-mutated ovarian cancer | This trial supported FDA approval | [84] | |
| II (NCT01891344; ARIEL2) | Platinum-sensitive high-grade ovarian cancer | This trial supported FDA approval and Foundation Medicine’s companion diagnostic | [85] | |
| III (NCT01968213; ARIEL3) | High-grade, recurrent, platinum-sensitive ovarian cancer | Supported FDA approval in 2018 for second-line therapy | [86,87] | |
| Niraparib | II (NCT02354586; QUADRA) | Ovarian cancer | This trial supported FDA approval as maintenance therapy | [88] |
| III (NCT01847274; ENGOT-OV16/NOVA) | Platinum-sensitive, recurrent ovarian cancer | This trial supported FDA approval as maintenance therapy | [89] | |
| Talazoparib | III (NCT01945775; EMBRC) | Advanced breast cancer | This trial supported FDA approval | [90] |
FDA: Food and Drug Administration; gBRCA: germline BRCA; TNBC: triple-negative breast cancer.