A Phase I Study of E7050 in Subjects With Solid Tumors

Eisai Co., Ltd.0 sites18 target enrollmentSeptember 2011

ConditionsSolid Tumor Gastric Cancer

InterventionsE7050

DrugsE7050

Overview

Phase: Phase 1
Intervention: E7050
Conditions: Solid Tumor
Sponsor: Eisai Co., Ltd.
Enrollment: 18
Primary Endpoint: Determination of the maximum tolerated dose (MTD)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2011

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Eisai Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

E7050

Intervention: E7050

Outcomes

Primary Outcomes

Determination of the maximum tolerated dose (MTD)

Time Frame: 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).