Date: 2014-06-09
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: metastatic hormone-refractory prostate cancer
Therapeutic area: Cancer - Oncology
Country: USA
Trial
details: The SHIP (Selinexor in Hormone Refractory Indications in Prostate Cancer) study is led by Drs. Christopher J. Logothetis and John Araujo of the M.D. Anderson Cancer Center at the University of Texas in Houston and is being funded in part by a grant from the Prostate Cancer Foundation. This is an open-label, Phase 2 clinical study of selinexor (KPT-330) in patients with metastatic castration-resistant prostate cancer (mCRPC). Approximately 50 qualifying patients with metastatic HRPC following at least one of the recently approved agents (enzalutamide, abiraterone or radium 223) will receive 50 mg/m2 of Selinexor orally twice per week over each 28-day cycle. The primary goal of the study is to determine the disease control rate assessed according to RECIST criteria and the prevention of new bone lesions. The secondary goal of the study is to evaluate the prostate-specific antigen (PSA) response relative to baseline. (NCT02146833)
Latest
news: * On June 9, 2014, Karyopharm Therapeutics announced the initiation of a Phase 2 trial of selinexor (KPT-330) in patients with metastatic hormone-refractory prostate cancer (HRPC). "We recently presented data at ASCO showing an 88% disease control rate, meaning stable disease or better, in eight evaluable patients with heavily pretreated prostate cancer," stated Dr. Sharon Shacham, Karyopharm's Founder, President and CSO. "These patients were treated in our Phase 1 clinical trial of Selinexor in advanced or metastatic solid tumors. All had progressive disease upon entering the study and had exhausted available therapies including taxane-based chemotherapy, and many had received newer agents such as enzalutamide and/or abiraterone. As a result of this encouraging data, we have initiated the SHIP Study, a Phase 2 study to further evaluate Selinexor's potential in patients with treatment-resistant prostate cancer."
