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Clinical Trials

Date: 2015-05-28

Type of information: Presentation of results at a congress

phase: 1-2

Announcement: presentation of results at the American Society of Clinical Oncology (ASCO) annual meeting, in Chicago

Company: Onxeo (France)

Product: belinostat

Action mechanism:

histone deacetylase inhibitorBelinostat 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: thymic epithelial tumors

Therapeutic area: Cancer - Oncology

Country:

Trial details:

Latest news:

* On May 28, 2015, Onxeo announced clinical data from studies supporting of the potential of belinostat in multiple orphan oncology indications. Abstract e18564 – Effect of treatment on the regression and growth rates of thymic epithelial tumors (TETs).3 Lead Author: Mauricio Burotto, M.D., Center for Cancer Research, National Cancer Institute, National Institutes of Health. The study used a mathematical model to characterize the effect of different therapies on the rate of tumor regression and the rate of tumor growth while a therapy is administered in thymic epithelial tumors (TETs), rare tumors with limited treatment options and limited standard measures of tumor response evaluation. The assessment included data from a total of 74 patients across four trials: one Phase I/II trial of belinostat in combination with cisplatin, doxorubicin, cyclophosphamide (NCT01100944) and three, single-agent Phase II clinical trials evaluating belinostat (NCT00589290), cixutumumab (NCT00965250) or sunitinib (NCT01621568).

The study showed rates of tumor regression of belinostat combination treatment were significantly higher compared to the other three therapies, which implies a clinically higher objective response rate. However, there were no significant differences in tumor growth rate between the four therapies (p = 0.83), indicating that while belinostat with chemotherapy may be used as initial therapy to render some disease resectable, novel therapies that can slow tumor growth and can be tolerated for prolonged periods of time are needed to significantly prolong overall survival in TETs.

Is general: Yes