Phase I study of chidamide (CS055/HBI-8000), a new histone deacetylase inhibitor, in patients with advanced solid tumors and lymphomas

Abstract

Chidamide was generally well tolerated in patients with advanced solid tumors or lymphomas in the tested regimens. Favorable PK and PD profiles, as well as encouraging preliminary anti-tumor activity, were demonstrated.

A phase II study of sunitinib in recurrent and/or metastatic adenoid cystic carcinoma (ACC) of the salivary glands: current progress and challenges in evaluating molecularly targeted agents in ACC

“…Based on these findings, a phase II study of vorinostat is underway (NCT01175980). One partial response was also reported in a preliminary report of a phase I study of CS055/HBI-8000 [32].…”

“…Median PFS and OS was 6.4 and 21 months, respectively, which seems comparable to that observed with sunitinib. Agents that inhibit histone deacetylases have been evaluated in ACC in two phase I trials [31,32]. Vorinostat was associated with one partial response and four patients with SD in a phase I trial of five assessable patients [31].…”

Development of chidamide for peripheral T-cell lymphoma, the first orphan drug approved in China

“…A phase I clinical study was conducted in patients with advanced solid tumors or lymphomas (20). A total of 31 patients were enrolled who received oral doses of 5, 10, 17.5, 25, 32.5, or 50 mg chidamide twice weekly (BIW), or 32.5 or 50 mg chidamide three-times weekly (TIW) for four consecutive weeks, followed by a two-week drug-free holiday.…”

Global histone post-translational modifications and cancer: Biomarkers for diagnosis, prognosis and treatment?

“…Due to their great successes in many studies, HDACi romidepsin and vorinostat have been approved by FDA as the treatment regime of cutaneous T-cell lymphoma, and romidepsin also for the treatment of relapsed peripheral T-cell lymphoma [84] . Since then many other HDACi have been under study of phase Ⅰ and/or Ⅱ trials as monotherapy, including belinostat, panobinostat, entinostat, chidamide, SB939 and LAQ824 in various cancers like ovarian, lung, soft tissue carcinoma, nonsmall-cell lung and breast [114][115][116][117][118][119][120][121] . However, unlike that of earlier success in treatment of lymphomas the majority of the results among solid tumor patients have been disappointing.…”