Date: 2011-03-14
Type of information:
phase: 2
Announcement: updates
Company: Topotarget (Denmark)
Product: belinostat
Action
mechanism: 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: ovarian cancer
non small cell lung cancer (NSCLC)
Therapeutic area: Cancer - Oncology
Country:
Trial
details: The study is an open-label single-arm phase II trial with belinostat in combination with carboplatin given to patients with ovarian cancer who progress during or shortly after first-line treatment with platinum containing chemotherapy. The trial is sponsored by the GOG with support from the NCI. Belinostat is administered as a 30-minute daily IV infusion on day one through five with carboplatin being administered on day three. Treatment is given every third week and is repeated until disease progression.
Latest
news: Topotarget has announced updates on belinostat in two clinical trials – NSCLC and ovarian cancer. Preliminary analysis of GOG 0126-T trial has not shown enough activity to enter into second stage. Consequently the study will be ended .Axel Mescheder, MD, CDMO says that according to NCI: “The preliminary analysis of the first stage of the GOG trial did not show enough activity to continue into stage 2. However, in the GOG trial, belinostat was combined with carboplatin only and this, in our minds, does not exploit the full potential of belinostat. This is clearly demonstrated in an earlier Topotarget-sponsored trial, CLN-8, where 21 heavily pretreated patients suffering from ovarian cancer showed encouraging activity of the BelCaP combination treatment (belinostat, carboplatin and paclitaxel – triple therapy) with a response rate of 24%, progression-free survival of 5.5 months and a progression-free survival at 6 months of 37%. The results from CLN-8 have been presented at the AACR-NCI-EORTC conference in 2008 and demonstrate that the BelCaP regimen warrants further investigation in a larger and controlled trial“. He continues: ”We will await more data from the NCI/GOG trial for thorough analysis. Further plans will be envisioned based on triple combination at a later stage in respect to our clinical development in ovarian cancer”.
