Table 2. Ongoing clinical trials in germline-mutated pancreatic cancer registered on Clinicaltrials.gov.
Trial ID | Phase | Number of patients | Status of trial | Countries involved | |
---|---|---|---|---|---|
NCT01296763[85] | A Randomised Multi-centre Phase I/II Trial of Irinotecan, Cisplatin, Mitomycin C (ICM) with or without olaparib (AZD2281) in Patients With Advanced Pancreatic Cancer | I | 18 | Completed, no phase II | US |
NCT01585805 [67] | A Randomised Phase II Study of Gemcitabine, Cisplatin +/−Veliparib in Patients With Pancreas Adenocarcinoma and a Known BRCA/PALB2 Mutation (Part I) and a Phase II Single Arm Study of Single-Agent Veliparib in Previously Treated Pancreas Adenocarcinoma | II | 107 | Recruiting | International (US, Canada, Israel) |
NCT02042378 [96] | A Phase 2, Open-Label Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation | II | 100 | completed | US, Israel |
NCT01489865 [66] | A Phase I/II Study of ABT-888 in Combination With 5-fluorouracil and Oxaliplatin (Modified FOLFOX-6) in Patients With Metastatic Pancreatic Cancer | I–II | 48 | recruiting | US |
NCT00515866 [97] | A Phase I, Open Label, Study of the Safety and Tolerability of KU-0059436 in Combination With Gemcitabine in the Treatment of Patients With Advanced Solid Tumours (Pancreatic Cancer) | I | 68 | completed | US, UK |
NCT01286987 [98] | A Phase 1, First in Human, Single-arm, Open-label Study of Once a Day, Orally Administered Talazoparib in Patients With Advanced or Recurrent Solid Tumours | I | 74 | ongoing, but not recruiting participants | US, UK |
NCT01339650 [99] | A Phase 1 Study of ABT-767 in BRCA1 or BRCA2 Mutation Carriers With Advanced Solid Tumours and in Subjects With High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | I | 75 | ongoing, but not recruiting participants | Netherlands |
NCT01989546 [100] | Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumours and Deleterious BRCA Mutations. | I–II | 42 | Recruiting | US |
NCT01233505 [101] | A Phase I Study of ABT-888 in Combination With Oxaliplatin and Capecitabine in Advanced Solid Tumours | I | 16 | terminated | US |
NCT02184195 [68] | A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Maintenance Olaparib Monotherapy in Patients With gBRCA Mutated Metastatic Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum Based Chemotherapy (POLO) | III | 145 | recruiting | International |
NCT02286687[102] | Phase II Study of the PARP Inhibitor BMN 673 (Talazoparib Tosylate) in Advanced Cancer Patients With Somatic Alterations in BRCA1/2, Mutations/Deletions in PTEN or PTEN Loss, a Homologous Recombination Defect, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation in BRCA1/2 (Not Breast or Ovarian Cancer). | II | 270 | ongoing, but not recruiting participants | US |
NCT00386399a [103] | Phase II Study of Mitomycin-C in Patients With Advanced or Recurrent Pancreatic Cancer With Mutated BRCA2 Gene | II | 29 | study has been withdrawn prior to enrolment | US |
aTrial withdrawn prior to enrolment due to all 29 consented subjects testing negative for the BRCA2 mutation.