Table 4.
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.