Table 4.
Ongoing Clinical Trials
| Clinical trial | Drug tested | Control | Study design | Population | N¶ | Primary outcome |
|---|---|---|---|---|---|---|
| Agents targeting DNA damage repair (DDR) - PARP inhibitors | ||||||
| NCT02184195 | Olaparib (maintenance) | Placebo | Phase 3, double blind RCT | gBRCA mutant metastatic PDAC | 154 | PFS |
| NCT01585805 | Gem/cis + Veliparib | Gem/Cis | Phase 2 RCT | BRCA/PALB2 mutant PDAC | 107 | Response rate by RECIST |
| NCT02890355 | mFOLFIRI + Veliparib | mFOLFIRI | Phase 2 RCT | Metastatic PDAC | 143 | mOS |
| NCT01489865 | Veliparib + mFOLFOX | NA | Phase 1/2 | Metastatic PDAC | 79 | DLT |
| NCT03553004 | Niraparib | NA | Phase 2, single arm | Previously treated metastatic PDAC | 18 | ORR (PR+SD) |
| NCT03337087 | Rucaparib + Nal-IRI + FU + leucovorin | NA | Phase 1/1 b, open label | Metastatic GI cancers§ | 110 | DLT, ORR |
| CDK inhibitors | ||||||
| NCT02501902 | Pablociclib + nab-P | NA | Phase 1, dose escalation trial | Metastatic PDAC | 77 | DLT |
| NCT02897375 | Palbociclib + Cis or Carboplatin | NA | Phase 1, dose escalation | Advanced solid tumors | 90 | RP2D, DLT |
| NCT02703571 | Ribociclib + Trametinib | NA | Phase 1/2, nonrandomized | Advanced PDAC/CRC | 150 | ORR, DLT |
| NCT02985125 | Ribociclib + everolimus | NA | Phase 1/2, nonrandomized | Metastatic CT resistant PDAC | 44 | PFS at 8 weeks |
| MEK inhibitor | ||||||
| NCT03637491 | talazoparib + Binimetinib + avelumab | Binimetinib + avelumab | Phase 1b/2 open label, RCT | LA/metastatic RAS mutant solid tumors‖ | 127 | DLT, ORR (CR+PR) |
| P53 targeting | ||||||
| NCT02340117 | SGT53 + Gem/nab-P | NA | Phase 2, single arm | Metastatic PDAC | 28 | PFS at 5.5 month |
| Other targets/lmmunotherapy | ||||||
| NCT01676259 | Gem/nab-P ± siG12D-L0DER | Gem/nab-P | Phase 2 RCT | LA PC | 80 | PFS |
| NCT02243371 | GVAX + CY + nivolumab Vs GVAX + CY | GVAX + CY + CRS-207 | Phase 2 RCT | Previously treated metastatic PDAC | 96 | mOS |
| NCT01896869 | Ipilimumab + GVAX | NA | Phase 2 RCT | Metastatic PDAC | 83 | mOS |
| NCT02383433 | Regorafenib + Gem | NA | Phase 2, single group | Previously treated metastatic PDAC | 2 | PFS |
| NCT01652976 | Dasatinib + FOLFOX | NA | Phase 2, single group | Metastatic PDAC | 58 | PFS |
| NCT02699749 | TAK-931† | NA | Phase 1, dose escalation | Advanced solid tumors | 100 | DLT |
Estimated sample size;
Pancreatic, colorectal, gastroesophageal and biliary tract cancers;
(PDAC, NSCLC, other RAS mutant solid tumors;
CDC7 (cell division cycle 7-related protein kinase).
RCT randomized controlled trial; gBRCA germline BRCA; PFS progression free survival; RECIST Response Evaluation Criteria in Solid Tumors; mFOLFIRI modified regimen containing Folic acid, Fluorouracil, Irinotecan; mOS median overall survival; mFOLFOX modified regimen containing Folic acid, Fluorouracil, Oxaliplatin; CRS-207 live attenuated Listeria monocytogenes strain; FOLFIRINOX Folic acid, Fluorouracil, Irinotecan, Oxaliplatin; NA not applicable; DLT dose limited toxicity; ORR objective response rate; CR complete response; PR partial response; NaI-IRI liposomal irinotecan; FU fluorouracil; GI gastrointestinal; nab-P nanoparticle albumin&-bound paclitaxel; SGT53 Study of Combined Targeted p53 Gene Therapy; RP2D recommended phase 2 dose; LA locally advanced.