Date: 2014-06-24
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: acute myeloid leukemia (AML)
Therapeutic area: Cancer - Oncology
Country: Canada, Denmark, Germany, Israel, Netherlands, Spain, UK, USA
Trial
details: The Selinexor in Older Patients with Relapsed/Refractory AML (SOPRA) study is a randomized trial of selinexor versus physician's choice, and will be conducted at approximately 40 sites worldwide including sites in the United States, Canada, Europe and Israel. Patients age ? 60 years with relapsed/refractory AML of any type except for AML M3, after one prior therapy only, who have never undergone and who are not currently eligible for stem cell transplantation and are currently deemed unfit for intensive chemotherapy. In SOPRA, 150 patients with AML which has relapsed after, or was refractory to, first line therapy will be randomized in a 2:1 fashion to Selinexor provided orally twice per week at a dose of 55mg/m2 versus one of four physician choices. Physician choices include best supportive care (BSC) alone, or BSC plus either azacytidine (Vidaza), decitabine (Dacogen), or low dose cytosine arabinoside (LD-AraC). Overall survival is the primary endpoint. SOPRA was designed based on data from the ongoing Phase 1 study of Selinexor in patients with advanced hematologic malignancies, including AML. SOPRA is expected to take approximately two years to complete. (NCT02088541)
Latest
news: * On June 24, 2014, Karyopharm Therapeutics announced the initiation of its Phase 2 study of selinexor (KPT-330) in patients 60 years of age or older with relapsed or refractory acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy and/or transplantation.
