Date: 2014-04-24
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Karyopharm Therapeutics (USA - MA)
Product: selinexor (KPT-330 - (Z)-3-(3-(3,5-bis(trifluoromethyl)phenyl)-1H-1,2,4-triazol-1-yl)-N'-(pyrazin-2-yl)acrylohydrazide)
Action
mechanism: selective inhibitor of nuclear export/nucleoside analogue. Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding to the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 300 patients have been treated with Selinexor in Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Additional Phase 1 and Phase 2 studies are ongoing or currently planned and three registration-directed clinical trials in hematological indications are expected to begin enrollment during 2014.
Disease: ovarian carcinoma, endometrial carcinoma, cervical carcinoma, breast cancer
Therapeutic area: Cancer - Oncology
Country: Belgium, Denmark
Trial
details: In the SIGN study, patients will receive selinexor at a dose of 50mg/m2, twice a week. The primary goal of the study is to determine the disease control rate assessed according to RECIST criteria. The secondary goal of the study is to evaluate safety and tolerability. Quality of life will also be evaluated. (NCT02025985)
Latest
news: * On April 24, 2014, Karyopharm Therapeutics announced the initiation of a Phase 2 trial of selinexor (KPT-330) in patients with advanced gynecologic malignancies including cervical, ovarian and uterine carcinomas.The study, referred to as the SIGN Study, is being led by Ignace Vergote, MD, at the University Hospitals, Leuven, Belgium. SIGN is also open at Rigshospitalet in Copenhagen, Aalborg University Hospital, Aalborg, and Herlev Hospital, Herlev, all in Denmark.
