Safety
death, pneumonia, febrile neutropenia, TEAEs, SAEs, TEAE
PNEUMONIA, FEBRILE NEUTROPENIA, ADVERSE EVENTS, EVENT, DISEASE, ADVERSE EVENT, EVENTS
The median (minimum and maximum) total treatment duration of the 14 patients was 1.5 (1 and 8) cycles. The median (minimum and maximum) relative dose intensity was 100% (92.9% and 100%), 100% (7.1% and 100%), and 92.9% (70.7% and 100%) in the 90-, 120-, and 160 mg cohorts, respectively. A summary of TEAEs is provided in Table Summary of treatment-emergent adverse events (TEAEs)Treatment-emergent adverse event (TEAE) is an adverse event that occurs after the first administration or worsens relative to the pretreatment stateCoded with Medical Dictionary for Regulatory Activities (MedDRA) Version 21.1Most frequent treatment-emergent adverse events (TEAEs) [≥ 20% (all grades) or any (grade ≥ 3)]Treatment-emergent adverse event (TEAE) is an adverse event that occurs after the first administration or worsens relative to the pretreatment stateCoded with Medical Dictionary for Regulatory Activities (MedDRA) Version 21.1DLT assessment was completed by all 11 patients in the MTD analysis set, and no DLTs were reported in any of the three cohorts during the evaluation period (cycle 1). The MTD was not reached, thus, recommended dose was defined as 160 mg in the 14/28 treatment cycle. The five reported SAEs in four patients included febrile neutropenia (two events) and pneumonia (three events). Both febrile neutropenia events and one pneumonia event were drug-related. No death or AEs that caused treatment discontinuation were noted. All patients discontinued study treatment due to progressive disease (