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Pharmocokinetic/Pharmacodynamic (PK/PD) Study of the Combination Cetuximab/Gefitinib

NCT00820417 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2009-01-12

No results posted yet for this study

Summary

This is an open-label, phase 1, non-randomised, non-controlled trial, carried out in two centres on patients with advanced cancer expressing EGFR. Primary objective is the determination of the maximum tolerated dose (MTD) and recommended dose (RD) of the combination of intravenous Cetuximab and oral Gefitinib.

Conditions

Interventions

DRUG

Cetuximab/Gefitinib combination and/or monotherapy

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • AstraZeneca

    collaborator INDUSTRY

  • Harrison Clinical Research

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2007-09-30
Completion
2008-05-31

Countries

  • Belgium
  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT00820417 on ClinicalTrials.gov