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Study of Irofulven in Combination With Oxaliplatin in Patients With Advanced Solid Tumors

NCT00374660 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2021-12-08

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD) and to investigate the efficacy, safety and pharmacokinetics of irofulven combined with oxaliplatin in patients with advanced solid tumors.

Conditions

Interventions

DRUG

Oxaliplatin

Oxaliplatin will be administered in a 2-hour infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 40 to 80 mg/m\^2 by dose escalations in 10 mg/m2 increments if no dose-limiting toxicity.

DRUG

Irofulven

Thirty minutes after completion of oxaliplatin infusion, irofulven will be administered as a 30-minute infusion on Days 1 and 15 of a 28-day cycle. The dose levels ranged from 0.30 to 0.40 mg/kg if no dose-limiting toxicity.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

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
2003-06-30
Primary Completion
2007-04-30
Completion
2007-04-30

Countries

  • France

Study Locations

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Entities

Drugs
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 NCT00374660 on ClinicalTrials.gov