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. 2016 Dec 26;8(7):12484–12500. doi: 10.18632/oncotarget.14226

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