AsianScientist (Mar. 6, 2012) – Cambridge, U.S.-based Millennium: The Takeda Oncology Company, with its parent company Takeda Pharmaceutical Company Limited, today announced the initiation of an international Phase III clinical trial evaluating MLN8237 in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), an aggressive form of lymphoma.
The multi-center study with MLN8237, an investigational, oral, selective inhibitor of Aurora A kinase, will be conducted in Europe, North America, Latin America, and the Asia-Pacific region.
“There is a significant unmet medical need for patients suffering from PTCL,” said Karen Ferrante, M.D., Chief Medical Officer, Millennium. “MLN8237 is being explored across a broad range of hematological malignancies and solid tumors.”
The study is a phase III, randomized, two-arm, open-label, multi-center, international trial of MLN8237 (alisertib) or investigator’s choice (selected single agent) in patients with relapsed or refractory PTCL.
The primary endpoints are overall response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, complete response (CR) rate, overall survival (OS), and time to progression (TTP).
PTCL comprises a group of rare and usually aggressive non-Hodgkin lymphomas that develop from mature T-cells. It accounts for approximately 10 to 15 percent of all NHL cases in the United States.
Source: Millennium: The Takeda Oncology Company.
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