Phase 1 Study of E7090 in Subjects With Solid Tumor

DLT was graded using Common Terminology Criteria for Adverse Events version 4.03 as follows: a. febrile neutropenia, or Grade 4 neutropenia persisting for greater than or equal to (>=) 7 days, b. Grade 4 thrombocytopenia, or Grade 3 thrombocytopenia requiring platelet transfusions, c. Grade >=3 non-hematological toxicity, except for: clinically insignificant laboratory abnormalities, toxicity Grade less than or equal to (<=) 2 by best supportive care; d. potentially clinically significant, new radiographic mineralization in soft tissue, kidneys, intestines, heart, lungs, or other organs; e. Hyperphosphatemia meeting either for: serum phosphate level greater than (>) 7 milligram per deciliter (mg/dL) persisting for >=7 days despite best treatment, serum phosphate level >9 mg/dL despite best treatment; f. treatment interruption for >=8 days during Cycle 0; Cycle 1 required by E7090-related toxicity, except for treatment interruption for >=8 days for reasons other than toxicity.

A TEAE was defined as an adverse event (AE) that emerged during the time from the first dose of study drug to 30 days following the last dose of study drug, having been absent at pretreatment (Baseline) or reemerged during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsened in severity during treatment relative to the pretreatment state, when the AE was continuous. A Serious AE is any untoward medical occurrence that at any dose: resulted in death; was life threatening (that is, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death) required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria.

OS was defined as the time from the date of first dose to the date of death from any cause. OS was estimated by using Kaplan-Meier method.

PFS was defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first). PD was defined as at least a 20 percent (%) increase in the sum of LD of target and non-target lesions as compared with the smallest sum of long diameter (LD) and the increase of LD was at least 5 millimeter (mm) (including new lesions). The tumor assessment is based on Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 criteria and was estimated using Kaplan-Meier method.

Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) was performed based on RECIST v1.1. Tumor marker was also measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) also evaluated. Best overall responses were complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE). CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >=7 weeks after first dose.

ORR was defined as a percentage of participants with BOR of CR or PR. ORR was assessed using RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with baseline summed LD.

DCR was defined as the percentage of participants with BOR of CR, PR or SD. DCR was assessed based on RECIST 1.1. CR was defined as disappearance of all target lesions and non-target lesions (a short diameter is <10 mm if it exists in a lymph node). PR was defined as at least 30% decrease in the sum of the LD of all target lesions, as compared with Baseline summed LD. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. SD was defined as no known evidence of progressive disease or new bone lesions where SD was achieved at >= 7 weeks after first dose.