Date: 2014-04-29
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: glioblastoma, glioma
Therapeutic area: Cancer - Oncology
Country: Denmark, The Netherlands, USA
Trial
details: The KING study is an open-label, multicenter, Phase 2 study to evaluate the efficacy and safety of oral selinexor in patients with recurrent gliomas. (NCT01986348)
Latest
news: * On April 29, 2014, Karyopharm Therapeutics announced the initiation of a Phase 2 trial of selinexor (KPT-330) in patients with glioblastoma following treatment with radiation and temozolomide. The KING study is being run by Drs. Morten Mau-Sørensen at the Rigshospitalet in Copenhagen, Denmark, Andrew Lassman at Columbia University, New York, and Patrick Wen, Dana Farber Cancer Institute, Boston, Massachusetts. Eligible patients have disease that has recurred after prior treatment with radiation therapy and temozolomide and may undergo surgery as required. The primary goal of the study is to determine the anti-tumor activity of single agent Selinexor in up to 30 patients with relapsed glioblastoma (grade 4 glioma), as well as to document brain penetration of Selinexor and determine tolerability in this population.
