Phase I Clinical Study of E7389

Phase 1

Completed

• Conditions: Cancer
• Interventions: Drug: E7389

• Registration Number: NCT00326950
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The primary objective of this study is to determine the dose limiting toxicity and maximum tolerated dose of E7389 in patients with solid tumors. The secondary objectives are to investigate the pharmacokinetics, safety, estimated recommended dose, and anti-tumor effects (in evaluable cases) of E7389 in patients with solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-16
• Study First Submitted QC: 2006-05-16
• Study First Posted: 2006-05-17
• Study Start: 2006-06
• Primary Completion: 2008-01
• Study Completion: 2008-02
• Results First Submitted: 2011-11-16
• Results First Submitted QC: 2011-11-16
• Results First Posted: 2011-12-20
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-06
• Last Update Posted: 2012-03-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E7389	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Who Experienced Dose Limiting Toxicity (DLT)	3 weeks	DLT is an adverse drug reaction defined as 1)Grade 4 neutropenia for 5 days, 2)\>/=Grade 3 febrile neutropenia, 3)\>/=Grade 3 neutropenia requiring iv antibiotics, 4)Grade 4 thrombocytopenia, 5)\>/=Grade 3 nonhematologic toxicity, 6)Omission of study drug on Day 8 due to \>/=Grade 3 neutropenia or thrombocytopenia or investigator decision.
Maximum Tolerated Dose (MTD)	3 Weeks	MTD was the lowest dose at which a dose limiting toxicity occurred.

Secondary Outcome Measures

Name	Time	Method
Safety, Tolerability, the Pharmacokinetics, a Recommended Dose (RD) for Phase II Clinical Study and the Anti-tumor Effect in Evaluable Subjects.	3 weeks