Table 2. Clinical trials of epigenetic drugs in kidney cancer.
Drug | Combined Therapy | Enzimatic Class | Approval Stage | Status | Indication | Results | Reference/Clinical trial identification |
---|---|---|---|---|---|---|---|
Vorinostat | Bevacizumab | HDAC inhibitor | Phase 1/2 | completed | Unresectable or metastatic kidney cancer | 48,6% of the patients had absence of disease progression at 6 months8,11% of the patients experienced serious adverse events | NCT00324870 |
Vorinostat | Isotretinoin | HDAC inhibitor | Phase 1/2 | Completed | Advanced renal cell carcinoma | MTD of Vorinostat in combination with isotretinoin=0,5 mg/kg | NCT00324740 |
Vorinostat | - | HDAC inhibitor | Phase 2 | Completed | Advanced renal cell carcinoma | An objective response was observed in 36% of the patients63% of the patients demonstrate progressive disease and one patient had serious adverse events | NCT00278395 |
Vorinostat | Pembrodizumab | HDAC inhibitor | Phase 1 | Ongoing | Advanced renal or urothelial cell carcinoma | Final data collection date for primary outcome measure: May 2018 | NCT02619253 |
Panobinostat | - | HDAC inhibitor | Phase 2 | Completed | Refractory clear cell renal carcinoma | Median of progression free survival=1,7 months 30% of the patients experienced serious adverse events |
Hainsworth et al. 2011 (NCT00550277) |
Panobinostat | Everolimus | HDAC inhibitor | Phase ½ | Terminated | Metastatic or unresectable renal cell cancer | The study has been terminated (patients off study, principal investigator left institute) | NCT01582009 |
Panobinostat | Sorafenib | HDAC inhibitor | Phase 1 | Ongoing | Advanced renal cell carcinoma | Study completion date: November 2016 | NCT01005797 |
Entinostat | Isotreitinoin | HDAC inhibitor | Phase 1 | Completed | solid tumor including kidney cancer, urothelial carcinoma and prostate cancer | No objective responses were observed but stable disease was noticed in patients with kidney, prostate and pancreatic cancerRecommended doses for phase 2: 4 mg/m of entinostat once weekly and 1mg/kg of isotretinoin per day | Pili et al. 2012 |
Entinostat | IL-2 | HDAC inhibitor | Phase 1/2 | Ongoing | Metastatic kidney cancer | No date given for study completion | NCT01038778 |
Decitabine | Interferon alpha2B | DNMT inhibitor | Phase 2 | Terminated | Advanced renal cell carcinoma | The study was terminated due to low accrual and unavailable treatment agent. | NCT00561912 |
Decitabine | IL-2 | DNMT inhibitor | Phase 1 | Completed | Melanoma or renal cell cancer | Three patients with renal cell cancer had stable disease | Gollob et al. 2006 |
GTI-2040 | Capecitabine | Antisense oligonucleotide that targets R2 subunit of ribonucleotide reductase | Phase 2 | Completed | Advanced/metatastic renal cell carcinoma | 52% of the patients had stable disease with median duration of 4 monthsOne partial response was observed | Desai et al. 2004 |
MG98 | - | Antisense oligonucleotide that targets DNMT1 | Phase 2 | Completed | Metastatic renal carcinoma | Six patients had stable disease but no objective responses were seen | Whinquist E. et al 2006 |
Oblimersen | Interferon alpha | Antisense oligonucleotide that targets bcl2 | Phase 2 | Completed | Metastatic renal cell cancer | No study results or publications provided | NCT00059813 |
MRX34 | RNA mimic | Phase 1 | Terminated | Renal cell carcinoma | This study was terminated due to serious adverse events | NCT01829971 |