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Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

NCT00507091 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2016-08-25

No results posted yet for this study

Summary

A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Conditions

Interventions

DRUG

ZD6474 (vandetanib) 100mg

once daily oral tablet

DRUG

Irinotecan

intravenous infusion

DRUG

5-Fluorouracil

intravenous infusion

DRUG

Leucovorin

intravenous infusion

DRUG

ZD6474 (vandetanib) 300mg

once daily oral tablet

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2006-05-31
Completion
2008-06-30

Countries

  • Belgium
  • United Kingdom

Study Locations

More Related Trials

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 NCT00507091 on ClinicalTrials.gov