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. Author manuscript; available in PMC: 2016 Dec 21.
Published in final edited form as: Pharmacol Ther. 2013 Jan 24;138(2):185–196. doi: 10.1016/j.pharmthera.2013.01.007

Table 4.

Clinical trials of HDACi for urological cancers.

Drug Clinical trial identifier Phase Status Protocol Outcome
Prostate
Panobinostat, docetaxel and prednisone NCT00663832 Phase I Completed CRPC received panobinostat 10, 15 or 20 mg i.v. on days 1 and 8 in combination with docetaxel i.v. on day 1 and prednisone p.o. 5 mg bid every day of a 21-day cycle. n=44 Determined the MTD of i.v. Panobinostat is 15 mg in combination with docetaxel and prednisone in patients with CRPC. 63% of patients showed >50% decline in PSA levels
Panobinostat, bicalutamide NCT00878436 Phase I/II Recruiting CRPC patients receiving panobinostat at either 60 or 120 mg per week for 2 consecutive weeks, with one week rest and bicalutamide 50 mg p.o. daily, continuously. Predicted enrolment: n=78 Investigating safety and efficacy of combined treatment of panobinostat at 2 dose levels combined with bicalutamide for CRPC as measured by time to PSA progression and proportion of patients that achieve a ≥50% PSA decline by 9 months of therapy
Vorinostat NCT00330161 Phase II Active, not recruiting Metastatic CRPC patients (PSA>5 ng/ml, disease progression, adequate organ function) received 400 mg vorinostat orally each day. n=27 7% patients achieved an objective response rate; no PSA decline>50% observed; significant toxicities reported
Romidepsin NCT00106418 Phase II Completed Metastatic CRPC patients received romidepsin 13 mg/m2 i.v. over 4 h on days 1, 8 and 15 every 4 weeks. n=35 2 patients reached a confirmed radiological partial response of >6 months, in addition to >50% PSA decline
Kidney
Panobinostat NCT00550277 Phase II Completed Metastatic RCC patients received 45 mg panobinostat twice per week for 8 week cycles with re-evaluation at the end of each cycle; n=20 No objective response observed; generally well-tolerated with minimal side effects
Romidepsin NCT00106613 Phase II Completed Metastatic RCC patients received 13 mg/m2 romidepsin i.v. on days 1, 8 and 15 over 4 week cycles with disease progression analyzed every 8 weeks. n=29 7% experienced an objective response. Terminated due to toxicity.