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A Dose Escalation Study of E7107 Administered Intravenously on Days 1 and 8 Every 21 Days to Patients With Solid Tumors

NCT00499499 · Status: SUSPENDED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-02-04

No results posted yet for this study

Summary

The purpose of this study is to investigate E7107 in patients with solid tumors. This is an open label, dose-escalation study of E7107. The maximum tolerated dose (MTD) of the single agent will be established by determining the occurrence of dose limiting toxicities during the first three weeks of therapy (Cycle 1). Patients in this study will be treated at multiple dose levels, starting at 0.6 mg/m\^2. Patients will receive E7107 as a 30-minute intravenous infusion on Days 1 and 8 every 21 Days.

Conditions

Interventions

DRUG

E7107

E7107 will be administered as an intravenous infusion over 30 minutes at a starting dose of 0.6 mg/m\^2 to the first cohort of patients. The same dose will be given on Days 1 and 8 of a 21-day cycle. Dose escalation will not occur until the maximum tolerated dose is reached. The selection of subsequent dose levels will be performed according to an accelerated design.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Ewa Matczak · Eisai Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2009-06-30
Completion
2010-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00499499 on ClinicalTrials.gov