Table 1.

Completed trials of PARP inhibitors in PDA patients

Trial number	Stage of study	PARP inhibitor (monotherapy or combination)	Number of PDA patients	Selection criteria (germline or somatic DDR mutations)	Primary outcome and key secondary outcome findings
NCT02184195	III	Olaparib	154	Germline BRCA	PFS 7.4 months PARP maintenance arm versus 3.8 months in placebo arm (HR .53, P = .004).
NCT01078662	II	Olaparib	23	Germline BRCA	RR 21.7%. No significant difference in RR between BRCA1 or BRCA2 mutants.
NCT02042378	II	Rucaparib	19	Somatic or Germline BRCA	RR 15.8%, with all responses observed in patients with platinum-sensitive disease.
NCT02184195	II	Veliparib	16	Germline BRCA and PALB2	RR 0%, with SD in 5 patients, all with platinum-sensitive disease. The tria was stopped early.
NCT01585805	II	Cisplatin and gemcitabine ± veliparib	50	Germline BRCA and PALB2	RR 74% in the triplet arm and 62.5% in the doublet arm. No significant difference in PFS and OS between the triplet and doublet arms
NCT01585805	I	Cisplatin, gemcitabine, and veliparib	17	Germline BRCA and BRCA WT patients	MTD at DL2. RR 77.8% in germline BRCA cohort and 0% in BRCA WT cohort.
NCT01296763	I	Olaparib, irinotecan, cisplatin, and mitomycin	18	Unselected	Addition of mitomycin was too toxic (3 DLTs) with 89% of the cohort experiencing G3/G4 AEs. The RR of all patients was 23%.
NCT01489865	I	FOLFOX plus veliparib	22	Germline BRCA, PALB2 or FANC mutation	RP2D of veLiparib 300 mg BID in addition to standard mFOLFOX 6 doses. RR of 14%, PFS 2.6 months and OS 5.4 months.

Abbreviations: Pancreatic adenocarcinoma—PDA; poly (ADP-ribose) polymerase—PARP; DNA damage repair—DDR; progression-free survival—PFS; hazard ration—HR; response rate—RR; recommended phase 2 dose—RP2D; maximum tolerated dose—MTD; dose level 2—DL2; overall survival—OS; grade—G; dose-limiting toxicity—DLT; adverse events—AEs