Date: 2011-04-26
Type of information: Initiation of preclinical development
phase: 1
Announcement: completion of patient recruitment
Company: Topotarget (Denmark)
Product: belinostat
Action
mechanism: histone deacetylase inhibitor. Belinostat is asmall molecule HDAC inhibitor being investigated for its role in the treatment of a wide range of solid tumors and hematologic malignancies either as a single agent, or in combination with other active anti-cancer agents, including carboplatin, paclitaxel, doxorubicin, idarubicin, cis-retinoic acid, azacytidine, 5-FU, etoposide and Velcade® (bortezomib) for injection. HDAC inhibitors represent a new mechanistic class of anti-cancer therapeutics that target HDAC enzymes, and have been shown to: Arrest growth of cancer cells (including drug-resistant subtypes); induce apoptosis, or programmed cell death; promote differentiation; inhibit angiogenesis; and sensitize cancer cells to overcome drug resistance when used in combination with other anti-cancer agents.
Disease: refractory or relapsed Hodgkin’s or Non-Hodgkin’s lymphoma
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The study is an open-label, multi-center Phase I dose escalation trial with oral belinostat given to patients with refractory or relapsed Hodgkin’s or Non-Hodgkin’s lymphoma as the second part of the development program of oral belinostat. In the first part, patients with advanced solid tumors (e.g. cancer of breast, ovary, head and neck, non-small cell lung, and others) were treated. Results have been presented at various scientific conferences, most recently at ASCO 2009.
Latest
news: * On July 23, 2014, BioAlliance Pharma and Topotarget announced that the cross-border merger between the two companies is legally effective as of 22 July 2014 to create Onxeo, dedicated to orphan oncology diseases.Topotarget has announced that the last patient has been recruited into the Topotarget- sponsored Phase I trial with oral belinostat. * On April 26, 2011, Pre-clinical data demonstrate that belinostat potently inhibits growth of human lymphoma cell lines of B- and T-cell malignancies. Moreover, clinical data have shown that intravenous belinostat is active in patients with peripheral and cutaneous T-cell lymphomas. The second part of the development program was initiated with the primary objective to examine the safety and tolerability profile, including the definition of the maximal tolerated dose (MTD) of oral belinostat given as monotherapy to patients with advanced lymphomas and secondarily to look at the efficacy. According to the dose escalation scheme, patients received capsules with doses ranging from 750 mg to 2,000 mg given in a discontinuous once daily dosing schedule (days 1-14 in a 21-day cycle). A total of 92 patients with solid tumors and 28 patients with lymphoma have been treated with belinostat in this study. Patients tolerating drug and showing signs of clinical benefit (stable disease, partial response or complete response) were eligible for multiple treatment cycles. Both complete and partial responses have been noted despite the advanced state of the patients who mostly were refractory after having received multiple prior treatment regimens. The treatment was well tolerated. Final results will become available in 2012 when the patients have finalized treatment.
