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

Mesothelioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00787410
• Other study ID #: 1839IL/0094
• Status: Completed
• Phase: Phase 2
• First received: November 6, 2008
• Last updated: June 5, 2012
• Start date: September 2003
• Est. completion date: April 2008

Study information

• Verified date: June 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Mesothelioma

Intervention

Drug:
• ZD1839
250mg tablet, once daily, orally administered

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure		Proportion of patients responding at trial closure, ITT population	No
Primary	To further characterize the safety profile of ZD1839 at a 250mg daily dose		Proportion of patients responding at trial closure, ITT population	Yes
Secondary	To estimate PFS (progression free survival)		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	No
Secondary	To estimate overall survival		Proportion of patients alive at trial closure, ITT population; Median time to death; Proportion of patients alive at 6 months	No
Secondary	To estimate duration of response		Median time from objective response to progression or death; only patients who responded are included in this analysis	No