A Study of E7080 in Subjects With Solid Tumor

A Phase 1 Study of E7080 in Subjects With Solid Tumor

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

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Drug: E7080

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Subjects with histologically and/or cytologically diagnosis of solid tumor
• Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
• Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
• Subjects who completed previous anti-tumor therapy before at least 4 weeks
• Subjects who are 20 years or older
• Subjects with 0 to 1 of Performance Status
• Subjects agree to be hospitalized for DLT observation
• Subjects with adequate organ functions
• Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
• Agree to participate in this study in writing based on voluntary will

Exclusion Criteria

• Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
• Subjects with the severe complication or disease history
• Subjects unable to take oral medication.
• Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
• Scheduled for surgery during the projected course of the study.
• Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
• Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
• Pregnant or nursing subjects
• Subjects who are participating in another clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1

Drug: E7080; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Dose Limiting Toxicity (DLT)		Up to 4 weeks
Number of Participants With Adverse Events	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).	Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).

Collaborators and Investigators

• Sponsor: Eisai Co., Ltd.
• Investigators: Study Director: Tatsuya Sasaki, Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 28, 2010
• First Submitted That Met QC Criteria: December 29, 2010
• First Posted (Estimated): December 30, 2010

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Cancer
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Lenvatinib
• Other Study ID Numbers: E7080-J081-105