Date: 2015-05-12
Type of
information: discontinuation of development
phase: 3
Announcement: halting of the trial
Company: Takeda Pharmaceutical (Japan)
Product: alisertib
Action
mechanism:
- kinase inhibitor/Aurora kinase inhibitor. Alisertib (MLN8237) is an oral, selective, inhibitor of Aurora A kinase being investigated by Takeda for the treatment of small cell lung cancer. Aurora A kinase is required for cells to divide properly and has been shown to be over-expressed in a variety of cancers, and inhibition of Aurora A kinase represents a novel approach in cancer research.
Disease: relapsed or refractory peripheral T-cell lymphoma (PTCL)
Therapeutic
area: Cancer - Oncology
Country:
Trial
details:
Latest
news:
- • On May 12, 2015 , Takeda Pharmaceutical Company announced that it has decided to discontinue the Phase 3 trial of alisertib
(MLN8237) for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) following the results of a pre-specified interim analysis that indicated the study is unlikely to meet the primary endpoint of superior progression-free survival (PFS) over the standard-of-care in this treatment setting. Takeda continues to investigate the utility of alisertib in small cell lung cancer (SCLC). Patients enrolled in the Phase 3 PTCL clinical trial who are being treated with alisertib may continue treatment if they are considered to be benefitting from treatment, and no safety concerns are present.
Is
general: Yes
