Selinexor: Phase II started
Karyopharm began the open-label, international Phase II SOPRA trial to evaluate 55 mg/m 2 oral selinexor twice weekly until disease progression, death or intolerance in 150 patients ages >=60 years with relapsed or refractory AML who are ineligible for intensive chemotherapy or transplantation. Patients will receive selinexor or 1 of 4 physician choices: best supportive care (BSC) alone or in combination with Vidaza azacitidine, Dacogen decitabine or low-dose cytosine arabinoside.
Selinexor is in Phase I and Phase II trials in advanced hematologic malignancies and solid tumors, including Phase II trials to treat relapsed glioblastoma, advanced gynecologic malignancies and refractory prostate cancer. This half, Karyopharm plans to start a pivotal Phase II/III trial for diffuse large B cell lymphoma (DLBCL). The product has Orphan Drug designation in the U.S. to treat AML and DLBCL. ...