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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00787410
Other study ID # 1839IL/0094
Secondary ID
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


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
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