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An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

NCT00787410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2012-06-06

No results posted yet for this study

Summary

This study is a multicentre, open label, non-comparative, two stage phase II trial to assess the activity of ZD1839 (IRESSA) in patients with malignant mesothelioma. Patients will receive trial treatment as first-line therapy, administered continuously once daily until the completion of six 4-week cycles of treatment, disease progression, unacceptable toxicity or withdrawal of consent. Patients continuing to show evidence of response, disease stabilization or clinical benefit from ZD1839 may continue to receive therapy beyond completion of the trail.

Conditions

Interventions

DRUG

ZD1839

250mg tablet, once daily, orally administered

Sponsors & Collaborators

Principal Investigators

  • Christopher Lee, MD · Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada

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
2003-09-30
Primary Completion
2008-04-30
Completion
2008-04-30

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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 NCT00787410 on ClinicalTrials.gov