NCT01428141

A Phase I Study of E7050 in Subjects With Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Solid Tumor
• Gastric Cancer

Interventions

Type	Name	Description
DRUG	E7050	Drug: E7050 The starting dose of E7050 will be 400 mg given orally, once-daily, in patients with advanced tumor that have progressed following effective therapy. The study consists of 2 parts: a Tolerability Confirmation Component to confirm the tolerable dose in subjects with solid tumor and an Expansion Component to confirm the safety and to preliminarily assess the anti-tumor activity in subjects with gastric cancer.

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2011-09-02
• Last updated: 2014-02-14

Locations

3 sites across 1 country: Japan