A Study of E7080 in Subjects With Solid Tumor

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: E7080

• Registration Number: NCT01268293
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-28
• Study First Submitted QC: 2010-12-29
• Study First Posted: 2010-12-30
• Study Start: 2011-02
• Primary Completion: 2011-12
• Study Completion: 2013-04
• Results First Submitted: 2015-02-21
• Results First Submitted QC: 2015-02-21
• Results First Posted: 2015-03-06
• Status Verified: 2016-08
• Last Update Submitted: 2023-06-16
• Last Update Posted: 2023-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E7080	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Dose Limiting Toxicity (DLT)	Up to 4 weeks
Number of Participants With Adverse Events	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).	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).