Date: 2016-07-06
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Debiopharm (Switzerland)
Product: Debio 1143 - (5S,8S,10aR)-N-benzhydryl-5-((S)-2-(methylamino)propanamido)-3-(3-methylbutanoyl)-6-oxodecahydropyrrolo[1,2-a][1,5]diazocine-8-carboxamide
Action
mechanism: Debio 1143 is an oral, small molecule inhibitor of IAPs (Inhibitor of Apoptosis Proteins) with a dual pro-apoptotic and immunomodulatory mode of action developed as a potent chemo/radio-sensitizer in oncology. The product has recently received Orphan Drug Designation from both the European Medicine Agency and the FDA.
Disease: epithelial ovarian cancer
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: * On June 7, 2016, Debiopharm announced the start of a clinical phase II study to evaluate the IAP inhibitor Debio 1143 for the treatment of epithelial ovarian cncer (EOC). This study is designed to evaluate the efficacy of Debio 1143 given in combination with carboplatin and paclitaxel in a neo-adjuvant setting as compared to chemotherapy alone. The trial aims at demonstrating the chemosensitizer effect of the compound in a double-blind design and at identifying biomarkers to be used for patients' stratification in pivotal studies. Safety and tolerability of Debio 1143 will also be evaluated by conventional endpoints.
