Date: 2011-03-14
Type of information: Recruitment of the first patient
phase: 1-2
Announcement: enrollment of the first patient
Company: Topotarget (Denmark) Spectrum Pharmaceuticals (USA)
Product: belinostat
Action
mechanism: histone deacetylase inhibitor. Belinostat is a small 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 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: non-small cell lung cancer
Therapeutic area: Cancer- Oncology
Country:
Trial
details: The study is an open-label single-arm phase I/II with belinostat in combination with carboplatin and paclitaxel in patients with previously untreated NSCLC. In phase I, the primary study objective is to determine the maximal tolerable dose of belinostat in combination with carboplatin and paclitaxel in the first-line treatment of patients with NSCLC. In the second stage of the study, the objective is to estimate the efficacy and safety of the combination. Belinostat is administered as a 30-minute daily IV infusion on day one through five with carboplatin and paclitaxel been administered on day three. Treatment is given every third week and is repeated until disease progression. The study is expected to recruit 35 patients.
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. * On March 23, 2011,Topotarget announced updates on belinostat in two clinical trials – NSCLC and ovarian cancer. The SPI-1014-Bel (Topotarget-Spectrum joint collaboration) trial has enrolled the first patient in the Topotarget/Spectrum-sponsored phase I/II trial of belinostat in combination with carboplatin and paclitaxel in patients with stage IV NSCLC (non-small cell lung cancer).
