Case Series of Cancer Patients Treated With Galunisertib, a Transforming Growth Factor-Beta Receptor I Kinase Inhibitor in a First-in-Human Dose Study

Analia Azaro, Jordi Rodon, Michael Carducci, Juan M. Sepulveda-Sanchez, Ivelina Gueorguieva, Ann L. Cleverly, Durisala Desaiah, Sokalingum P. Namaseevayam, Matthias Holdhoff, Michael M. Lahn

Abstract


Galunisertib (LY2157299 monohydrate) is a first-in-class small molecule inhibitor (SMI) of the transforming growth factor-beta (TGF-beta) signaling pathway. Some adverse events were associated with galunisertib during the first-in-human dose (FHD) study. Among these adverse events (n = 11) were four cases of infection, two cases of thromboembolic events and two cases of thrombocytopenia. In one of the patients with thromboembolic events, an autopsy was also performed to examine possible changes of the aorta. No significant histopathologic changes were observed. Single cases of grade 2 diarrhea (only associated with drug intake), stroke (after resection for relapsed glioma), and pre-existing co-primary tumor (possible colorectal cancer) were observed. Because TGF-beta plays an important role in tissue homeostasis and in immune response regulation, the present case series may serve as a future reference for adverse events observed in subsequent clinical trials with galunisertib.




J Med Cases. 2014;5(11):603-609
doi: http://dx.doi.org/10.14740/jmc1966w

Keywords


TGF-beta Inhibitor; Galunisertib; First-in-human study; Glioma; Adverse events; Case reports

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