Clinical trial · Interventional
An Open-label, Phase II Trial of ZD1839 (IRESSA) in Patients With Malignant Mesothelioma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ZD1839 | Drug | Gefitinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: ZD1839
Primary outcomes (2)
- measure
- To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure
- timeFrame
- Proportion of patients responding at trial closure, ITT population
- measure
- To further characterize the safety profile of ZD1839 at a 250mg daily dose
- timeFrame
- Proportion of patients responding at trial closure, ITT population
Secondary outcomes (3)
- measure
- To estimate PFS (progression free survival)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available