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Clinical Trials

Date: 2015-10-13

Type of information: Initiation of the trial

phase: 2-3

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: dedifferentiated liposarcoma

Therapeutic area: Cancer - Oncology

Country: Canada, USA

Trial details:

This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245 total patients will be randomized to study treatment (selinexor or placebo). (NCT02606461)

Latest news:

* On October 13, 2015, a Phase 2-3 trial sponsored by Karyopharm Therapeutics was published on the NIH website ClinicalTrials.gov for selinexor and is currently recruiting participants.

Is general: Yes