Date: 2014-05-01
Type of information: Initiation of the trial
phase: 1-2
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: LGH447/PIM447 and BYL719
Action
mechanism: kinase inhibitor/pan-PIM kinase inhibitor. LGH447 is a novel, specific pan-Pim kinase inhibitor in development for the treatment of patients with multiple myeloma (MM) and other hematologic malignancies. The PIM (Provirus Integration site for Moloney leukemia) kinase gene family encodes 3 serine/threonine protein kinases that have roles in cell cycle progression and survival. In human disease, elevated levels of Pim1 and Pim2 are associated with hematologic malignancies, with MM showing the highest level of Pim2 expression.
Disease: relapsed and refractory multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Australia, Germany, Italy, Hong Kong, Republic of Korea , Singapore, Spain, USA
Trial
details: This is a Phase Ib/II study with the primary purpose of the Phase Ib part being to estimate the MTD and/or recommended phase 2 dose (RP2D) of the combination of LGH447 and BYL719 when administered orally to adult patients with relapsed and refractory multiple myeloma. Once the MTD and/or RP2D is determined for the combination of LGH447 and BYL719, additional patients will be enrolled in the Phase II part to determine whether the combination of LGH447 and BYL719 exhibits improved anti-multiple myeloma activity compared to single agent LGH447. (NCT02144038)
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