Tab. 3.
Main ongoing clinical trials investigating DNA methyltransferases inhibitors (DNMTi) and histone deacetylase inhibitors (HDACi) in colorectal cancer.
| N | Drug | Phase | Design | Status | Trial Identifiers |
|---|---|---|---|---|---|
| 1 | Azacitidine and Entinostat | II | Open Label; Azacitidine and Entinostat in Patients with mCRC | Completed | NCT01105377 |
| 2 | Decitabine | I/Proof of Principle Study | Open Label; Pre-operative Decitabine in Colon Cancer to assess whether short-course preoperative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment biopsies | Recruiting | NCT01882660 |
| 3 | Cyclophosphamide (CY), Allogenic Colon Cancer Cell Vaccine (GVAX), and SGI-110 | I/Pilot Study | Randomized; SGI-110 in Combination with GVAX and CY in mCRC as Maintenance Therapy | Recruiting | NCT01966289 |
| 4 | Azacitidine and CAPOX | I/II | Open label; to assess MTD of Azacitidine and CAPOX and its efficacy in mCRC Enriched for Hypermethylation of CpG Promoter Islands | Completed | NCT01193517 |
| 5 | Pembrolizumab and Azacitidine | II | Open Label; to assess the activity, safety, and tolerability of Pembrolizumab + Azacitidine in chemo-refractory mCRC | On-going, but not recruiting | NCT02260440 |
| 6 | Epacadostat in Combination with Pembrolizumab and Azacitidine | I/II | Open label, single-arm; to assess safety, tolerability and anti-tumor efficacy of Epacadostat in combination with Pembrolizumab plus Azacitidine in patients with chemo-refractory MSS mCRC. | Not open yet | NCT03182894 |
| 7 | Azacitidine and Durvalumab | II/Basket Study | Open label; to assess the antitumor activity of azacitidine with durvalumab in MSS-CRC and others solid tumors | Recruiting | NCT02811497 |
| 8 | Decitabine and Panitumumab | I | Open label; to assess safety, feasibility and activity of Decitabine and Panitumumab in 2nd or 3rd line for KRAS WT mCRC | Completed | NCT00879385 |
| 9 | Decitabine by HAI | I/II | Open label; to establish the recommended dose and activity of Decitabine by HAI in liver-predominant mCRC | Recruiting | NCT02316028 |
| 10 | SGI-110 Combined With Irinotecan vs Regorafenib or TAS-102 | I/II | Randomized open label; to assess safety and activity of SGI-110 Combined with Irinotecan versus Regorafenib or TAS-102 in refractory mCRC | Recruiting | NCT01896856 |
mCRC: metastatic colorectal cancer; CY: cyclophosphamide; GVAX: Allogenic Colon Cancer Cell Vaccine; CAPOX: capecitabine and oxaliplatin; MTD: