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 |