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. 2020 Jun 17;8:486. doi: 10.3389/fcell.2020.00486

TABLE 2.

Clinical trials of HDAC inhibitors: characteristics of clinical trials registered in https://clinicaltrials.gov.

Title Treatment Characteristics Condition Phase Dates NCT Number
Vorinostat in Treating Patients With Metastatic or Unresectable Melanoma Vorinostat • Enrollment : 32 patients with advanced melanoma
• Administration : dose of 400 mg for 28 consecutive days per cycle
• Adverse events : fatigue, nausea, lymphopenia, and hyperglycemia
• Outcome : 2 partial response and 16 stable disease (median PFS of 5 months), 14 progressive disease (median PFS of 4 months)
Melanoma Phase 2 • Study Start :
September 2005
• Study Completion :
June 2013
NCT00121225
NPI-0052 and Vorinostat in Patients With Non-small Cell Lung Cancer, Pancreatic Cancer, Melanoma or Lymphoma NPI-0052 (marizomib) Vorinostat • Enrollment: 22 patients with melanoma, pancreatic carcinoma or Non-small Cell Lung Cancer (NSCLC)
• Administration: doses of weekly marizomib in combination with vorinostat 300 mg daily for 16 days in 28 day cycles
• Adverse events : fatigue, nausea, vomiting, diarrhea, anorexia, dyspnoea, headache, infusion site pain
• Outcome : 61% stable disease, 39% partial response
Non-Small Cell Lung CancerPancreatic CancerMelanoma LymphomaMultiple Myeloma Phase 1 • Study Start :
March 2008
• Study Completion :
January 2010
NCT00667082
A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers Belinostat Cisplatin Etoposide • Enrollment : 28 patients with histologically or cytologically confirmed cancers for which there is no known standard therapy capable of extending life expectancy
• Administration : doses of belinostat 400 mg/m2 on days 1and 2, cisplatin 80 mg/m2 on day 2, and etoposide 100mg/m2 daily times 3 on days 2 to 4
• Outcome : 11 partial response, 13 stable disease, and 4 progressive disease
Carcinoma NeuroendocrineSmall Cell Lung CarcinomaMalignant Epithelial Neoplasms Phase 1 • Study Start :
July 1, 2009
• Study Completion :
April 20, 2018
NCT00926640
Panobinostat (LBH589) in Patients With Metastatic Melanoma Panobinostat • Enrollment : 16 patients with metastatic melanoma that is amenable to serial biopsies
• Administration : doses of LBH589 three days a week(Monday, Wednesday and Friday) every other weak
• Adverse events : thrombocytopenia, lymphocytopenia, LFT elevation, hypophosphatemia, hypokalemia Outcome : 27% stable disease, 73% progressive disease
Malignant Melanoma Phase 1 • Study Start :
February 2010
• Study Completion :
March 13, 2017
NCT01065467
A Safety and Dose-finding Study of JNJ-26481585 for Patients With Advanced Solid Malignancies and Lymphoma. Quisinostat • Enrollment : 22 with advanced solid tumors or lymphomas that were refractory to standard therapy
• Administration : doses of quisinostat once a day for 21 days cycle
• Adverse events: fatigue, cardiac disorder, decreased appetite, ventricular tachycardia, lethargy, and vomiting
• Outcome: 3 partial response, and 6 stable disease
LymphomaNeoplasmsa Phase 1 • Study Start :
August 2007
• Study Completion :
September 2011
NCT00677105
Selective HDAC6 Inhibitor ACY-241 in Combination With Ipilimumab and Nivolumab ACY-241 Nivolumab Ipilimumab • Enrollment : 1 patient with advanced melanoma
• Administration : doses of ACY-241 in combination with ipilimumab and nivolumab every 3 weeks for 4 doses each during a 12-week
Malignant Melanoma Phase 1 • Study Start :
September 30, 2016
• Study Completion :
April 7, 2017
NCT02935790
HDAC Inhibitor Vorinostat in Resistant BRAF V600 Mutated Advanced Melanoma Vorinostat • Enrollment : 21 patients with BRAF V600 mutated melanoma who developed resistance to BRAFi and/or BRAFi+MEKi
• Administration : dose of vorinostat 360 mg once daily
Melanoma Skin Neoplasms Phase 1Phase 2 • Study Start :
June 2016
• Primary Completion :
October 2019
NCT02836548