A Phase I Study of E7050 in Subjects With Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumor; Gastric Cancer
• Interventions: Drug: E7050

• Registration Number: NCT01428141
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-01
• Study First Submitted QC: 2011-09-01
• Study First Posted: 2011-09-02
• Primary Completion: 2013-01
• Study Completion: 2013-07
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-13
• Last Update Posted: 2014-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
E7050	E7050	-

Primary Outcome Measures

Name	Time	Method
Determination of the maximum tolerated dose (MTD)	During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)	Determination of the MTD of E7050 given orally once daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT).