An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

Phase 1

Completed

• Conditions: Cancer: Solid Tumors
• Interventions: Drug: E7080

• Registration Number: NCT00280397
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study is to determine the maximum tolerable dose (MTD) and the related effects of E7080 administered to patients with solid tumors that are resistant to approved existing anti-tumor therapies, or for which no appropriate treatment is available.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2008-09
• Study Completion: 2008-11
• 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: 2016-08-29
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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
Maximum Tolerable Dose (MTD) of E7080 Repeatedly Administered Twice a Day	up to 4 weeks	The MTD was defined as the highest dose at which no dose limiting toxicity (DLT) was experienced by the first 3 patients in that cohort, or the dose at which a DLT was experienced by no more than 1 of 6 patients evaluable for toxicity.
DLT of E7080 Repeatedly Administered Twice a Day	up to 4 weeks	DLTs were defined as grade 3 or more platelet count decrease, grade 4 neutropenia, any grade 3 or more nonhematologic toxicity (with exceptions of grade 4 hypertension not controlled by any antihypertensive drugs and grade greater than or equal to 3 vomiting and diarrhea not controlled by antiemetic or antidiarrheal drugs), and failure to administer more than 75% of the planned doses of E7080 during the same cycle due to toxicity.

Secondary Outcome Measures

Name	Time	Method
To Elucidate the Pharmacokinetic Profile of E7080	Every 3 weeks
To Make Exploratory Analyses of Pharmacodynamic Markers	Every 3 weeks
Number of Participants With Adverse Events / Serious Adverse Events	Until tumor progression, unacceptable toxicity, or withdrawal due to other reasons.	Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated.
Determine the Clinical Dose for Phase II Study Based on Safety and Pharmacokinetic Profile	Every 3 weeks
Evaluate the Anti-tumor Activity of E7080	Every 3 weeks