Date: 2014-12-11
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: diffuse large B-cell lymphoma (DLBCL)
Therapeutic area: Cancer - Oncology
Country: Austria, Belgium, Bulgaria, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Serbia, Spain, UK, USA
Trial
details: Randomized two-arm, multicenter, open-label Phase 2b study of 2 doses of selinexor (KPT-330) high in patients with relapsed/refractory de novo DLBCL who have no therapeutic options of demonstrated clinical benefit. (NCT02227251)
Latest
news: * On December 11, 2014, Karyopharm Therapeutics announced the initiation of the SADAL study, (Selinexor and Dexamethasone in Aggressive Lymphoma), a registration-directed, Phase 2b study of selinexor (KPT-330), in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL).This open-label Phase 2b study will evaluate the safety and efficacy of high dose (100 mg) versus mid dose (60 mg) Selinexor in combination with low dose (8-12 mg) dexamethasone for supportive care, each given orally to approximately 200 patients (100 per arm) with relapsed/refractory DLBCL. Overall response rate (ORR) is the primary endpoint. The study is expected to take approximately two years to complete and is intended to support accelerated regulatory approval.
