Table 2.
Ongoing trials with DDR-targeting agents in PDA patients
| Trial number |
Stage of study |
DDR agent (monotherapy or combination) |
Accrual target (patient number) |
Selection criteria (germline or somatic DDR mutations) |
Primary outcome |
|---|---|---|---|---|---|
| NCT03140670 | II | Maintenance rucaparib | 42 | Germline or somatic BRCA and PALB2 mPDA patients who do not progress on platinum chemotherapy | 6-month PFS |
| NCT02890355 | II | FOLFIRI ± veliparib | 143 | 2nd-line mPDA patients, unselected by DDR status | OS |
| NCT03553004 | II | Niraparib | 18 | 2nd-line mPDA patients with germline or somatic DDR (unspecified) mutations | RR |
| NCT03337087 | I/II | Flurouracil, nanoliposomal irinotecan, and rucaparib | 110 (not all mPDA patient) | Later-line mPDA patients for phase I, untreated mPDA with HR mutations (somatic or germline) | |
| RP2D of phase I, RR in PDA patients with HR mutations in phase II | |||||
| NCT02677038 NCT02511223 |
II | Olaparib | 34 | 2nd-line and beyond germline BRCA-negative PDA patients with DDR mutations or family history of BRCA-associated malignancies | RR |
Abbreviations: DNA damage repair—DDR; pancreatic adenocarcinoma—PDA; response rate—RR; recommended phase II dose—RP2D; homologous recombination—HR; overall survival—OS