Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

E7080

Tatsuya Sasaki

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors

A Study of E7080 in Subjects With Solid Tumor

A Phase 1 Study of E7080 in Subjects With Solid Tumor

Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0, laboratory tests, vital signs (blood pressure \[mm Hg\], heart rate \[beats per minute\], body temperature \[degree C\], and body weight \[kg\]), 12-lead electrocardiograms (ECGs; heart rate \[bpm\], QT \[msec\] and QTc \[msec\]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).

Eisai Co., Ltd.

E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.

Age, Continuous

Male

Female

Sex/Gender, Customized

Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.

Number of Participants With Dose Limiting Toxicity (DLT)

The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.

Spots Global Cancer Trial Database for A Study of E7080 in Subjects With Solid Tumor

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