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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00787410
First received: November 6, 2008
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Mesothelioma
 Drug: ZD1839
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma

Resource links provided by NLM:

MedlinePlus related topics: Mesothelioma
Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure [ Time Frame: Proportion of patients responding at trial closure, ITT population ] [ Designated as safety issue: No ]
  • To further characterize the safety profile of ZD1839 at a 250mg daily dose [ Time Frame: Proportion of patients responding at trial closure, ITT population ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To estimate PFS (progression free survival) [ Time Frame: Proportion of patients alive and progression-free at trial closure, ITT population; Median time to progression or death; Proportion of patients alive and progression-free at 6 months ] [ Designated as safety issue: No ]
  • To estimate overall survival [ Time Frame: Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months ] [ Designated as safety issue: No ]
  • To estimate duration of response [ Time Frame: Median time from objective response to progression or death; only patients who responded are included in this analysis ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: September 2003
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: ZD1839
250mg tablet, once daily, orally administered
Other Name: IRESSA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-confirmed malignant mesothelioma (based on pleural biopsy); eligibility for first line therapy for malignant mesothelioma
  • Uni or bi- dimensionally measurable disease
  • No prior radiotherapy within 3 weeks of enrolment into the trial
  • No significant comorbid disease

Exclusion Criteria:

  • Other malignancies, either co-existing or diagnosed within the last 5 years, with the exception of basal cell carcinoma or cervical cancer in situ
  • Brian metastasis or leptomeningeal carcinomatosis
  • Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
  • Concomitant use of phenytoin, carbamazepine, barbiturates, rifampicin, or St. John's Wort
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00787410

Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Christopher Lee, MD Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00787410     History of Changes
Other Study ID Numbers: 1839IL/0094
Study First Received: November 6, 2008
Last Updated: June 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
malignant mesothelioma
IRESSA
ZD1839

Additional relevant MeSH terms:
Mesothelioma
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Mesothelial
Gefitinib
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013