Table 3.
Clinical trials involving DNA methylation inhibitors listed on.www.clinicaltrials.gov.
| Trial ID | Status | Enrollment | Interventions | Conditions | Purpose |
|---|---|---|---|---|---|
| NCT01193517 | Completed | 26/14 | 5-Azacitidine and CAPOX | Metastatic CRC | Phase I: To find the highest tolerable dose of azacitidine combined with CAPOX that can be given to patients with metastatic CRC. Phase II: To study efficacy and safety of combination can help to control CIMP metastatic CRC. |
| NCT02260440 | Completed | 31 | 5-Azacitidine and Pembrolizumab | Chemo-refractory metastatic CRC | Phase II: To evaluate the anti-tumor activity, safety, and tolerability of Pembrolizumab in combination with azacitidine in subjects with chemo-refractory mCRC without any further standard treatment options. |
| NCT01105377 | Completed | 47 | 5-Azacitidine and Entinostat | Metastatic CRC | Phase II: To study how well giving azacitidine together with entinostat works in treating patients with metastatic CRC. |
| NCT02959437 | Completed | 70 | 5-Azacitidine with Pembrolizumab and Epacadostat | Advanced or metastatic solid tumors | Phase I/II: Dose-escalation assessment to evaluate the safety and tolerability of the combination therapies. |
| NCT03182894 | Withdrawn | 0 | 5-Azacitidine with Pembrolizumab and Epacadostat | chemo-refractory MSS mCRC | Phase IB/II: To evaluate the safety, tolerability and anti-tumor efficacy of epacadostat in combination with pembrolizumab plus azacitidine in patients with chemo-refractory MSS mCRC. |
| NCT02811497 | Active | 28 | 5-Azacitidine and Durvalumab | MSS CRC PR-OC ER+ and HER2- BC | Phase 2: To assess the antitumor activity of azacitidine in combination with durvalumab in advanced solid tumors. |
| NCT02316028 | Completed | 11 | Decitabine | Unresectable Liver Metastatic CRC | PhaseI: Toxicity and efficacy of Decitabine delivered by HAI in patients with non-resectable liver metastatic CRC. |
| NCT00879385 | Completed | 21 | Decitabine and Panitumumab | Advanced metastatic CRC | To evaluate the safety and feasibility of the sequential use of decitabine with panitumumab for KRAS wild type tumors in the second or third line treatment of advanced mCRC. |
| NCT01882660 | Terminated | 88 | Decitabine | Stage II-III CRC | Phase I: To assess in patients with primary colon cancer whether short-course pre-operative treatment with decitabine can increase Wnt target gene expression as measured in resected tumors compared to pretreatment biopsies. |
| NCT01966289 | Active | 18 | SGI-110 with CY and GVAX | Metastatic CRC | Phase I: Difference in CD45RO+ TILs measured by immunohistochemistry in pre and post-treatment tumor biopsies from mCRCs. To evaluate the efficacy, safety and tolerability of treatment. |
| NCT01896856 | Completed | 96 | SGI-110 combined with irinotecan versus regorafenib or TAS-102 | Previously treated mCRC | Phase I: To determin MTD of SGI-110 combined with irinotecan. Phase II: To evaluate the efficacy of SGI-110 and irinotecan versus the standard of care regorafenib or TAS-102. |
| NCT03576963 | Recruiting | 45 | SGI-110 Plus Nivolumab | Refractory CIMP+ mCRC | Phase Ib: To study the side effects and best dose of SGI-110 Plus Nivolumab. Phase II: To assess the efficacy of SGI-110 Plus Nivolumab |
CIMP, CpG island methylator phenotype; CAPOX, capecitabine and oxaliplatin; MSS, microsatellite stable; CRC, colorectal cancer;
ER, estrogen receptor; BC, breast cancer; PR-OC, platinum resistant epithelial ovarian cancer type II; NSCLC, non-small cell lung cancer;
HAI, hepatic arterial infusion; GVAX, allogeneic colon cancer cell vaccine; CY, cyclophosphamide; TILs, tumor infiltrating lymphocytes;
MTD, maximum tolerated dose.