Takeda’s Oral Proteasome Inhibitor MLN9708 Enters Ph III Study In Japan
Tech & Pharma
November 26, 2013
Takeda has initiated enrollment of patients in Japan in an ongoing global Phase III clinical study of its novel oral proteasome inhibitor MLN9708.
AsianScientist (Nov. 26, 2013) – Takeda Pharmaceutical Company has initiated enrollment of patients in Japan in an ongoing global Phase III clinical study of its novel oral proteasome inhibitor MLN9708 (ixazomib citrate) in relapsed and/or refractory multiple myeloma.
The Phase III, randomized, double-blind, multi-center, international study will compare MLN9708 with lenalidomide and dexamethasone to placebo as well as lenalidomide and dexamethasone in patients with relapsed and/or refractory multiple myeloma.
The study was initiated in Europe, North America and the Asia-Pacific region in June 2012. The primary endpoint is progression-free survival (PFS). Secondary endpoints include overall survival (OS), OS in high-risk patients, overall response rate (ORR), duration of response (DOR), time to progression (TTP), safety, and QOL.
MLN9708 is a proteasome inhibitor and is the first to enter clinical trials as an oral preparation. Currently, Phase III clinical studies are ongoing in newly diagnosed multiple myeloma and in relapsed and/or refractory AL amyloidosis as well as in relapsed and/or refractory multiple myeloma.
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