Karyopharm’s (NASDAQ:KPTI) Phase II/III SEAL study (NCT02606461) of selinexor in dedifferentiated liposarcoma has been slow to recruit at some centers and may encounter accrual challenges due to disease rarity, inclusion criteria and randomization, investigators said.
The CRO for the study is Parexel (NASDAQ:PRXL), an investigator said, and while possible, it is unlikely any recruitment issues would be CRO-related.
Rather, he noted, the inclusion criteria requires patients to have received at least one prior therapy, making it more difficult to find those who qualify among the dedifferentiated liposarcoma patient pool. For patients with de novo disease, they have to wait four to five months -- to receive an initial line of systemic treatment -- before being able to enter the selinexor study. A second investigator said his center receives about 10 dedifferentiated liposarcoma patients per year, and there were patients in the middle of treatment with other therapies waiting to be ready to enter SEAL.