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: Non-compartmental PK analysis was conducted for three patients from cohort 1, six patients from cohort 2, and six patients from cohort 3; one patient was excluded from PK analysis due to a dosing error (protocol deviation). The mean serum concentration versus time profiles following the first and multiple doses of olaratumab infusion are shown in Figure 2(a,b) respectively. The second peak, occurring at approximately 169 h for the 10 mg/kg (cohort 1) and 15 mg/kg (cohort 3) dose groups, is associated with the second infusion of olaratumab given on day 8 (168 h).
Affiliation: National Cancer Center Hospital East, Kashiwa, Chiba, Japan.