Table 4 Overview of NAE inhibitors in clinical trials
Drugs | With combination | Phase | Trial number | Cancer | Year (first posted) | Patients number and sponsor | Intervention model | Status |
|---|---|---|---|---|---|---|---|---|
MLN4924 | Alone | I | NCT00677170 | Nonhematologic Malignancies | 2008 | 62; Millennium Pharmaceuticals, Inc | Single group assignment | Completed |
| Â | Alone | I | NCT00722488 | MM, HM, HL, Lymphoma | 2008 | 56; Millennium Pharmaceuticals, Inc | Single group assignment | Completed |
| Â | Azacitidine | I | NCT00911066 | AML, MDS, ALL | 2009 | 72; Millennium Pharmaceuticals, Inc | Single group assignment | Completed |
| Â | Alone | I | NCT01011530 | Metastatic melanoma | 2009 | 37; Millennium Pharmaceuticals, Inc | Single group assignment | Completed |
| Â | Azacitidine | I | NCT01814826 | AML | 2013 | 64; Millennium Pharmaceuticals, Inc | Sequential Assignment | Completed |
| Â | Docetaxel, Gemcitabine, Carboplatin, Paclitaxel | I | NCT01862328 | Solid tumor | 2013 | 64; Millennium Pharmaceuticals, Inc | Sequential assignment | Completed |
| Â | Fluconazole, Itraconazole, Docetaxel, Carboplatin, Paclitaxel | I | NCT02122770 | Solid tumor | 2014 | 51; Millennium Pharmaceuticals, Inc | Parallel assignment | Completed |
| Â | Docetaxel, Carboplatin, Paclitaxel | I | NCT03057366 | Solid tumor | 2017 | 8; Millennium Pharmaceuticals, Inc | Sequential assignment | Completed |
| Â | Temozolomide, irinotecan | I | NCT03323034 | Recurrent or refractory solid tumors or lymphoma | 2017 | 30; Children's Oncology Group | Single group assignment | Active, not recruiting |
| Â | Docetaxel, Carboplatin, Paclitaxel | I | NCT03330106 | Advanced solid neoplasm | 2017 | 68; Millennium Pharmaceuticals, Inc | Crossover assignment | Completed |
| Â | Rifampin, Docetaxel, Carboplatin, Paclitaxel | I | NCT03486314 | Advanced solid neoplasm | 2018 | 20; Millennium Pharmaceuticals, Inc | Sequential assignment | Completed |
| Â | Cytarabine | I | NCT03459859 | AML and MDS | 2018 | 12; Justin Watts, MD | Parallel assignment | Completed |
| Â | Ruxolitinib | I | NCT03386214 | Myelofibrosis | 2017 | 8; Washington University School of Medicine | Sequential assignment | Terminated |
| Â | Ibrutinib | I | NCT03479268 | CLL or Non-HL | 2018 | 18; City of Hope Medical Center | Single group assignment | Active, not recruiting |
| Â | Decitabine | I | NCT03009240 | AML | 2017 | 30; City of Hope Medical Center | Single group assignment | Active, not recruiting |
| Â | Vincristine, Dexamethasome, PEG-asparaginase, Doxorubicin, Cytarabine, Methotrexate, Hydrocortisone | I | NCT03349281 | ALL | 2017 | 6; Julio Barredo, MD | Parallel assignment | Completed |
| Â | Azacitidine | I | NCT02782468 | Leukemia, Myeloid, MS | 2016 | 23; Millennium Pharmaceuticals, Inc | Parallel assignment | Completed |
| Â | Belinostat | I | NCT03772925 | AML, MDS | 2018 | 30; National Cancer Institute | Single group assignment | Active, not recruiting |
| Â | Azacitidine | I | NCT03814005 | MDS, CMML and AML | 2019 | 17; Takeda | Sequential assignment | Completed |
| Â | Ixazomib citrate | I | NCT03770260 | MM | 2018 | 8; National Cancer Institute | Single group assignment | Active, not recruiting |
| Â | Azacitidine, Fludarabine, Phosphate, Cytarabine | I | NCT03813147 | AML, MDS | 2019 | 12; National Cancer Institute | Single group assignment | Active, not recruiting |
| Â | Azacitidine (or Decitabine) and Venetoclax | I | NCT04172844 | AML | 2019 | 24; Medical College of Wisconsin | Sequential assignment | Active, not recruiting |
| Â | Azacitidine | II | NCT02610777 | MDS, CMML and AML | 2015 | 120; Millennium Pharmaceuticals, Inc | Parallel assignment | Completed |
| Â | Docetaxel | II | NCT03228186 | Non-small cell lung cancer | 2017 | 31; University of Michigan Rogel Cancer Center | Single group assignment | Terminated |
| Â | Azacitidine | II | NCT03238248 | MDS, MPN | 2017 | 71; Vanderbilt-Ingram Cancer Center | Single group assignment | Active, not recruiting |
| Â | Azacitidine | II | NCT03745352 | Relapsed or Refractory AML | 2018 | 0; National Cancer Institute | Parallel assignment | Withdrawn |
| Â | Azacitidine | II | NCT03709576 | Non-Remission AML | 2018 | 3; Milton S. Hershey Medical Center | Single group assignment | Terminated |
| Â | Carboplatin, Paclitaxel | II | NCT04175912 | Bile duct cancer | 2019 | 52; National Cancer Institute | Parallel assignment | Active, not recruiting |
| Â | Carboplatin, Paclitaxel | II | NCT03965689 | Advanced non-small cell lung cancer | 2019 | 24; National Cancer Institute | Single group assignment | Active, not recruiting |
| Â | Azacitidine | Unknown | NCT04484363 | MDS | 2020 | Intermediate-size population; Takeda | Unknown | No longer available |
| Â | Pembrolizumab | I/II | NCT04800627 | Locally advanced unresectable solid tumor | 2021 | 2; M.D. Anderson Cancer Center | Single group assignment | Terminated |
| Â | Decitabine, Cedazuridine | II | NCT04985656 | MDS | 2021 | 0; Takeda | Single group assignment | Withdrawn |
| Â | Azacitidine | II | NCT04712942 | AML, MDS | 2021 | 14; University of Leipzig | Parallel assignment | Completed |
| Â | Venetoclax, Azacitidine | II | NCT04266795 | AML in adults unable to receive intensive chemotherapy | 2020 | 164; Takeda | Parallel assignment | Active, not recruiting |
| Â | Azacitidine, Venetoclax | I/II | NCT03862157 | Newly diagnosed AML | 2019 | 51; M.D. Anderson Cancer Center | Single group assignment | Active, not recruiting |
| Â | Cytarabine, Idarubicin | I/II | NCT03330821 | AML | 2017 | 53; University of Southern California | Single group assignment | Active, not recruiting |
| Â | Etoposide, Prednisone, Vincristine, Cyclophosphamide, Doxorubicin, Rituximab, Filgrastim | I/II | NCT01415765 | Lymphoma | 2011 | 0; National Cancer Institute | Single group assignment | Withdrawn |
| Â | Pemetrexed | I/II | NCT03319537 | Mesotheliomas | 2017 | 9; Memorial Sloan Kettering Cancer Center | Sequential assignment | Active, not recruiting |
| Â | Azacitidine | III | NCT03268954 | MDS, CMML and AML | 2017 | 454; Takeda | Parallel assignment | Active, not recruiting |
| Â | Azacitidine | III | NCT04090736 | AML not eligible for standard chemotherapy | 2019 | 302; PETHEMA Foundation | Parallel assignment | Active, not recruiting |
TAS4464 | Alone | I | NCT02978235 | MM or lymphoma | 2016 | 11; Taiho Oncology, Inc | Single group assignment | Terminated |
| Â | Alone | I | JapicCTI-173,488 | Advanced/metastatic solid tumors | 2017 | Unknown; Japan Pharmaceutical Information Center | Unknown | Unknown |