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. Author manuscript; available in PMC: 2022 Jan 1.
Published in final edited form as: Cancer J. 2021 Nov-Dec;27(6):465–475. doi: 10.1097/PPO.0000000000000554

Table 4.

Ongoing phase 2 or 3 studies of PARPi in pancreatic cancer. Status as of July 21, 2021. Trials may be open to other tumor types, visit clinicaltrials.gov for the latest information.

PARPi ClinicalTrials.gov Identifier (Name) Trial Phase Setting Drugs Status
Olaparib NCT04666740
(POLAR)
Non-randomized phase 2 Maintenance after first or second-line therapy for metastatic disease.
Germline mutations in homologous recombination (BRCA 1, BRCA2, PALB2, ATM, BAP1, BARD1, BLM, BRIP1, CHEK2, FAM175A, FANCA, FANCC, NBN, RAD50, RAD51, RAD51C, RTEL1)
Platinum sensitive or resistant.
Pembrolizumab + Olaparib Recruiting
NCT04548752 Randomized phase 2 Maintenance therapy in metastatic disease with germline BRCA1 or BRCA2 mutations after first line platinum-based chemotherapy Pembrolizumab + Olaparib
Olaparib monotherapy
Recruiting
NCT02677038 Non-Randomized phase 2 Metastatic and with mutations in homologous recombination (e.g. somatic BRCA mutation, FANC1, ATM or RAD51 mutations) or in patients with close family members with BRCA-driven cancers
Negative for germline BRCA1 and BRCA2 mutations
After at least one prior line of chemotherapy for metastatic disease and not have platinum-refractory cancer
Olaparib monotherapy Active, not recruiting
NCT04858334
(APOLLO)
Randomized phase 2 Adjuvant therapy following completion of surgery and chemotherapy
Germline or somatic BRCA1, BRCA2 or PALB2 mutation
Olaparib monotherapy
Placebo
Recruiting
NCT02498613 Non-randomized phase 2 Maintenance therapy in advanced and metastatic pancreatic cancer Cediranib + Olaparib Recruiting
NCT03682289 Non-randomized phase 2 Maintenance therapy in locally advanced or metastatic pancreatic cancer following at least one previous line of therapy AZD6738 + Olaparib
AZD6738
Recruiting
Rucaparib NCT04171700
(LODESTAR)
Non-randomized phase 2 Maintenance therapy in unresectable, locally advanced, or metastatic solid tumors with deleterious mutations in BRCA1, BRCA2, PALB2, RAD51C or RAD51D. An expansion cohort is planned for patients with deleterious mutations in BARD1, BRIP1, FANCA, NBN, RAD51 or RAD51B.
Following at least one but not more than three prior lines of systemic therapy
Rucaparib monotherapy Recruiting
Niraparib NCT03601923 Non-randomized phase 2 Maintenance therapy in metastatic or locally advanced pancreatic cancer with germline or somatic mutations in BRCA1, BRCA2, PALB2, CHEK2 or ATM.
No progression on prior oxaliplatin-containing regimens
Niraparib monotherapy Recruiting
NCT04409002 Non-randomized phase 2 Metastatic pancreatic cancer Niraparib + Dostarlimab + Radiation Recruiting
NCT03553004
(NIRA-PANC)
Non-randomized phase 2 Metastatic pancreatic cancer with germline or somatic mutations in genes involved in DNA repair following progression after 1–2 lines of chemotherapy Niraparib Monotherapy Recruiting
NCT04493060 Non-randomized phase 2 Metastatic pancreatic cancer with germline or somatic BRCA1, BRCA2, or PALB2 mutations.
Following progression on 1–2 prior lines of chemotherapy for metastatic disease, with prior exposure to a platinum agent.
Niraparib + Dostarlimab Recruiting
NCT03404960
(PARPVAX)
Randomized Phase 1b/2 Maintenance therapy for locally advanced or metastatic pancreatic cancer with stable disease after at least 16 weeks of platinum-based treatment Niraparib + Nivolumab
Niraparib + Ipilimumab
Recruiting
Talazoparib No identified phase 2 or 3 trials
Veliparib NCT02890355 Randomized phase 2 Metastatic pancreatic cancer with recurrence following one prior systemic regimen
BRCA1, BRCA2, or other defects in homologous recombination repair
Veliparib + mFOlFIRI
FOLFIRI
Active, Not Recruiting
NCT01585805 Randomized phase 2 Locally advanced or metastatic pancreatic cancer with BRCA1, BRCA2, or PALB2 mutation.
No prior treatment allowed for Arms A and B (GCV vs GC), up to two prior treatments allowed for Arm C (single agent veliparib)
Gemcitabine + Cisplatin and veliparib
Gemcitabine + cisplatin
Veliparib monotherapy
Active, not recruiting
Fluzoparib NCT04300114 Randomized Double-Blind Phase 3 Maintenance therapy in patients with BRCA1/2 or PALB2-mutated pancreatic cancer that has not progressed on first-line platinum-based chemotherapy Fluzoparib
Placebo
Recruiting

GCV = Gemcitabine, cisplatin, veliparib. GC = Gemcitabine, Cisplatin, mFOLFIRI = modified fluorouracil, leucovorin, irinotecan.