Status:
COMPLETED
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
Lead Sponsor:
AstraZeneca
Conditions:
Mesothelioma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00787410
Start Date
September 1 2003
End Date
April 1 2008
Last Update
June 6 2012
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