TABLE 2.
Selected Ongoing Clinical Trials for Patients With Metastatic Pancreatic Cancer
| Categories | ClinicalTrials.gov Trial No. | Phase | Drugs | Mechanism of Action | Key Endpoint(s) |
|---|---|---|---|---|---|
| Stromal targeting | NCT01621243 | 1, 2 | Phase 1: GN and necuparanib Phase 2: GN ± necuparanib |
Necuparanib (M402): heparin sulfate mimetic | Phase 1: DLTs Phase 2: OS |
| NCT01839487 | 2 | GN ± PEGPH20 | PEGPH20: pegylated recombinant hyaluronidase | PFS | |
| NCT01959139 | 1, 2 | Phase 1: FOLFIRINOX and PEGPH20 Phase 2: FOLFIRINOX ± PEGPH20 |
PEGPH20: pegylated recombinant hyaluronidase | Phase 1: DLT Phase 2: OS |
|
| NCT02715804 | 3 | GN ± PEGPH20 | PEGPH20: pegylated recombinant hyaluronidase | PFS, OS | |
| NCT02345408 | 1 | FOLFIRINOX, CCX872-B | CCX872-B: CCR2 inhibitor | PFS | |
| NCT02436668 | 2, 3 | GN ± ibrutinib | Ibrutinib: Bruton tyrosine kinase inhibitor | PFS | |
| NCT02562898 | 1, 2 | GN and ibrutinib | Ibrutinib: Bruton tyrosine kinase inhibitor | DLT | |
| Immunotherapy | NCT01876511 | 2 | MK-3475 | MK-3475 (pembrolizumab): anti-PD-1 antibody | PFS |
| NCT01896869 | 2 | Arm A: ipilimumab and GVAX Arm B: FOLFIRINOX |
GVAX: vaccine against mesothelin-expressing cancer cells Ipilimumab: anti-CTLA-4 antibody | OS | |
| NCT02243371 | 2 | CY, GVAX, and CRS-207 ± nivolumab | GVAX: vaccine against mesothelin-expressing cancer cells CRS-207: modified Listeria that promotes mesothelin expression Nivolumab: anti-PD-1 antibody | OS | |
| NCT02472977 | 1, 2 | Phase 1: ulocuplumab and nivolumab Phase 2: Arm A: ulocuplumab and nivolumab Arm B: investigator’s choice | Ulocuplumab: CXCR4 antibody | MTD, ORR, OS | |
| NCT02558894 | 2 | MEDI4736 ± tremelimumab | MEDI4736: anti-PD-L1 antibody Tremelimumab: anti-CTLA-4 antibody | ORR | |
| NCT02620423 | 1 | Pembrolizumab, pelareorep, and chemotherapy (gemcitabine, irinotecan, or 5-FU/LV) | Pelareorep: oncolytic virus targeting RAS-mutant cells | DLT | |
| NCT02548169 | 1 | Dendritic cell vaccine and chemotherapy (FOLFIRINOX or GN) | DLT | ||
| NCT02268825 | 1, 2 | MK-3475, FOLFOX | MK-3475 (pembrolizumab): anti-PD-1 antibody | DLT | |
| NCT02672917 | 1 | MVT-5873 ± chemotherapy | MVT-5873: monoclonal antibody targeting CA 19-9 | MTD | |
| DNA damage response | NCT01489865 | 1, 2 | 5-FU/LV, oxaliplatin, ABT-888 | ABT-888 (veliparib): PARPi | DLT |
| NCT01585805 | 2 | Part 1: veliparib, gemcitabine, and cisplatin Arm B: gemcitabine and cisplatin Part 2: veliparib | Veliparib: PARPi | Part 1: DLT Part 2: ORR |
|
| NCT02184195 | 3 | Arm A: olaparib Arm B: placebo | Olaparib: PARPi | PFS | |
| Novel cytotoxic agents and combinations | NCT02581501 | 1 | GN and capecitabine | DLT | |
| NCT02324543 | 1, 2 | Gemcitabine, docetaxel, capecitabine, cisplatin, and irinotecan | DLT, OS | ||
| NCT02333188 | 1, 2 | 5-FU/LV, irinotecan, and nab-paclitaxel | DLT | ||
| NCT01893801 | 1, 2 | Nab-paclitaxel, cisplatin, and gemcitabine | ORR | ||
| NCT01954992 | 3 | Arm A: glufosfamide Arm B: 5-FU | Glufosfamide: novel alkylating agent | OS | |
| NCT02620800 | 1, 2 | 5-FU/LV, nab-paclitaxel, bevacizumab, and oxaliplatin | Phase 1: DLT Phase 2: 1-y OS |
||
| NCT02551991 | 2 | Arm A: nanoliposomal irinotecan, 5-FU/LV, and oxaliplatin Arm B: nanoliposomal irinotecan, 5-FU/LV Arm C: nab-paclitaxel and gemcitabine | PFS | ||
| NCT02080221 | 2 | FOLFOX and nab-paclitaxel | OS | ||
| Cancer stem cell targeting | NCT02651727 | 1 | GN and VS-4718 | VS-4718: focal adhesion kinase inhibitor | DLT |
| NCT02289898 | 2 | GN ± demcizumab | Demcizumab: delta-like ligand 4 antibody | PFS | |
| NCT02671890 | 1 | Gemcitabine ± disulfiram | Disulfiram: acetaldehyde dehydrogenase inhibitor | DLT | |
| NCT02546531 | 1 | Gemcitabine, pembrolizumab, and defactinib | Defactinib: focal adhesion kinase inhibitor | DLT | |
| NCT02231723 | 1 | Arm A: GN and BBI608 Arm B: FOLFIRINOX and BBI608 Arm C: FOLFIRI and BBI608 Arm D: 5-FU/LV, BBI608, and MM-398 | BBI608: STAT, stem cell inhibitor | DLT | |
| NCT02050178 | 1 | GN and OMP54F28 | OMP54F28: WNT pathway antagonist | DLT | |
| NCT02005315 | 1 | GN and vantictumab | Vantictumab: WNT signaling inhibitor | DLT | |
| NCT02077881 | 1, 2 | GN and indoximod | Indoximod: IDO pathway inhibitor | Phase 1: DLT Phase 2: OS |
|
| Targeted therapies and others | NCT02352831 | 1, 2 | Tosedostat | Tosedostat: aminopeptidase inhibitor | Phase 1: DLT Phase 2: PFS |
| NCT02574663 | 1 | Arm A: TGR-1202 Arm B: GN and TGR-1202 Arm C: FOLFOX and TGR-1202 Arm D: FOLFOX, bevacizumab, and TGR-1202 | TGR-1202: PI3K delta inhibitor | DLT | |
| NCT02501902 | 1 | Nab-paclitaxel and palbociclib | Palbociclib: CDK4/6 inhibitor | DLT | |
| NCT02514031 | 1 | GN and beta-lapachone | Beta-lapachone: novel 1,2-naphthoquinone | DLT | |
| NCT02468557 | 1 | Arm A: Idelalisib Arm B: Nab-paclitaxel and idelalisib Arm C: FOLFOX and idelalisib | Idelalisib : PI3K delta inhibitor | DLT | |
| NCT02451553 | Afatinib and capecitabine | Afatinib: EGFR/HER2 inhibitor | DLT | ||
| NCT02178436 | 1, 2 | GN and KPT-330 | KPT-330: selective inhibitor of nuclear export inhibitor | Phase 1: DLT Phase 2: OS |
|
| NCT02227940 | 1 | Arm A: Ceritinib and gemcitabine Arm B: Ceritinib and GN Arm C: Ceritinib, gemcitabine, and cisplatin |
Ceritinib: ALK inhibitor | DLT | |
| NCT02155088 | 1 | GN and BYL719 | BYL719: PI3K alpha inhibitor | DLT | |
| NCT02146313 | 1 | DMUC4064A | Antibody-drug conjugate to MUC16 | DLT | |
| NCT02154737 | 1 | Gemcitabine and erlotinib | DLT | ||
| NCT02138383 | 1 | GN and enzalutamide | Enzalutamide: nonsteroidal antiandrogen | MTD | |
| NCT01783171 | 1 | Dinaciclib and MK-2206 | Dinaciclib: CDK4 inhibitor MK-2206: AKT inhibitor | DLT | |
| NCT01924260 | 1 | Gemcitabine and alisertib | Alisertib: aurora kinase A inhibitor | DLT | |
| NCT01506973 | 1, 2 | Hydroxychloroquine, gemcitabine, and nab-paclitaxel | Hydroxychloroquine: antimalarial drug, inhibits autophagy | OS | |
| NCT02048384 | 1, 2 | Metformin ± rapamycin | Rapamycin: mTOR inhibitor | Safety and feasibility | |
| NCT02650804 | 2 | BPM31510 and gemcitabine | BPM31510: small molecule targeting cancer metabolism | ORR | |
| NCT02570711 | 2 | GN ± ACP-196 | ACP-196: Bruton tyrosine kinase inhibitor | ORR | |
| NCT02329717 | 2 | PBI-05204 | PBI-05204 : Oleander derivative, inhibitor of AKT, FGF-2, NF-Kb, and p70S6K | OS | |
| NCT02340117 | 2 | SGT-53 and GN | SGT-53: nanoliposomal delivery method targeting p53 | PFS | |
| NCT02399137 | 2 | GN ± MM-141 | MM-141: IGF-1R and ErbB3 bispecific antibody | PFS | |
| NCT02080260 | 2 | Regorafenib | Regorafenib: oral multityrosine kinase inhibitor | PFS | |
| NCT01905150 | 2 | Gemcitabine, 5-FU/LV, irinotecan, and oxaliplatin ± vitamin C | 1-y OS | ||
| NCT01834235 | 1, 2 | GN ± NPC-1C | NPC-1C: monoclonal antibody targeting colon and pancreatic cancer cells | OS | |
| NCT01666730 | 2 | FOLFOX and metformin | OS | ||
| NCT01652976 | 2 | FOLFOX and dasatinib | Dasatinib: oral multi-tyrosine kinase inhibitor | PFS | |
| NCT02244489 | 1 | Capecitabine, oxaliplatin, and momelotinib | Momelotinib: JAK1/2 inhibitor | DLT | |
| NCT02101021 | 3 | GN ± momelotinib | Momelotinib: JAK1/2 inhibitor | OS |
Abbreviations: 5-FU/LV, 5-fluorouracil/leucovorin; ALK, anaplastic lymphoma kinase; CCR2, C-C chemokine receptor type 2; CCX872-B, C-C chemokine receptor type 2 (CCR2) antagonist; CTLA-4, cytotoxic T-lymphocyte-associated protein 4; CXCR4, C-X-C motif chemokine receptor 4; DLT, dose-limiting toxicity; EGFR, epidermal growth factor receptor; FGF-2, fibroblast growth factor 2; FOLFIRINOX, 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin; FOLFOX, 5-fluorouracil, leucovorin, and oxaliplatin; GN, gemcitabine and nab-paclitaxel; HER2, human epidermal growth factor receptor 2; IDO, indoleamine 2,3-dioxygenase; IGF-1R, insulin-like growth factor receptor 1; JAK1/2, Janus kinase 1/2; MTD, maximum tolerated dose; mTOR, mammalian target of rapamycin; NF-kB, nuclear factor kB; ORR, objective response rate; OS, overall survival; PARPi, poly(ADP-ribose) polymerase inhibitors; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1 PFS, progression-free survival; PI3K, phosphoinositide 3-kinase.