Phase I study of olaratumab in Japanese patients with advanced solid tumors.
Bottom Line: The most common olaratumab-related treatment-emergent adverse events (TEAEs) were proteinuria (25.0%) and elevated aspartate transaminase (12.5%).One patient (cohort 2) had two olaratumab-related Grade 3 TEAEs (increased aspartate aminotransferase and tumor hemorrhage); otherwise, olaratumab-related TEAEs were Grade 1/2.Seven patients (43.8%) had a best response of stable disease.
Affiliation: National Cancer Center Hospital East, Kashiwa, Chiba, Japan.Show MeSH
Related in: MedlinePlus
Mentions: Comparative analyses of clearance (steady state clearance; CLss) and exposure (area under the concentration versus time curve during one dosing interval; AUCτ), following multiple infusions of olaratumab 20 mg/kg q2w, were conducted between this study of Asian patients and the US phase 1 study of non-Asian patients.(14) The results of this analysis are presented in Figure 3. As shown in the figure, the PK parameters CLss and AUCτ appear to be comparable between Asian and non-Asian patients. However, due to the small sample size, a statistical analysis was not conducted.
Affiliation: National Cancer Center Hospital East, Kashiwa, Chiba, Japan.