Results
pneumonitis, confusion, neutropenia, seizures, leukopenia, toxicities, hyperglycemia, lymphopenia, mucositis, anorexia
PNEUMONITIS, NEUTROPENIA, LEUKOPENIA, THROMBOCYTOPENIA, DISEASE, HEPATIC FAILURE, SOLID TUMOR, HYPERGLYCEMIA, LYMPHOPENIA, MUCOSITIS, ANOREXIA
Sixteen patients, 15 of whom were previously treated (median 3 prior lines of therapy), were enrolled. Major grade 3–4 non‐hematologic toxicities included mucositis (3 patients) and hyperglycemia (2 patients) as well as hepatic failure, seizures, confusion, pneumonitis, and anorexia (1 patient each). Grade >2 hematological toxicity included leukopenia (3), lymphopenia (2), thrombocytopenia, and neutropenia (1). The best response was stable disease in 2 patients (12.5%), while only 3 patients (19%) were able to proceed to Cycle 2. Pharmacokinetic analysis demonstrated drug exposures similar to those observed in solid tumor patients. Immunoblotting in serially collected samples indicated limited impact of treatment on phosphorylation of mTOR pathway substrates such as 4EBP1, S6, and AKT.