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

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00787410

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:	Marc Zarenda, AstraZeneca Canada
ClinicalTrials.gov Identifier:	NCT00787410 History of Changes
Other Study ID Numbers:	1839IL/0094
Study First Received:	November 6, 2008
Last Updated:	May 10, 2011
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 23, 2012