Date: 2015-10-19
Type of information: Initiation of the trial
phase: 1-2
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: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Canada, USA
Trial
details: The Selinexor and Backbone Treatments of Multiple Myeloma Patients, (STOMP) study is a multi-center, Phase 1b/2 study of selinexor and other standard therapies in patients with multiple myeloma (MM). This study will independently assess the efficacy and safety of two combination therapies for the treatment of patients with relapsed/refractory multiple myeloma (RR MM): selinexor + dexamethasone + pomalidomide (SdP), selinexor + dexamethasone + bortezomib (SdB), and selinexor + dexamethasone + lenalidomide (SdL). (NCT02343042)
Latest
news: * On October 19, 2015, Karyopharm Therapeutics announced the initiation of the Selinexor and Backbone Treatments of Multiple Myeloma Patients, (STOMP) study. Selinexor will be evaluated in combination with low-dose dexamethasone in independent cohorts with bortezomib (Velcade®), lenalidomide (Revlimid®) and pomalidomide (Pomalyst®). This multi-arm Phase 1b/2 study will evaluate the safety and efficacy of selinexor and low-dose dexamethasone at 60mg and 20mg, respectively, twice weekly or 80mg and 40mg, respectively, once weekly in separate combinations with either bortezomib, lenalidomide or pomalidomide. 220 patients with MM whose disease has relapsed after one or more prior therapies are expected to enroll in STOMP and overall response rate (ORR) is the primary endpoint of the study. STOMP was designed based on both preclinical combination data as well as from Karyopharm's ongoing Phase 1/2 study of selinexor with low-dose dexamethasone in combination with the proteasome inhibitor carfilzomib in relapsed/refractory multiple myeloma. Phase 1/2 data demonstrating the activity of selinexor with low-dose dexamethasone in combination with carfilzomib were presented at ASH 2014. In this ongoing study conducted by investigators at the University of Chicago, the first three patients, all of whom had MM refractory to carfilzomib and dexamethasone, were treated with selinexor, dexamethasone and carfilzomib achieved at least partial responses.
