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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mesothelioma

Intervention: ZD1839 (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Christopher Lee, MD, Principal Investigator, Affiliation: Fraser Valley Cancer Centre Surrey Memorial Hospital, Surrey BC, Canada

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.

Clinical Details

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

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

Primary outcome:

To assess the activity of ZD1839 in patients with malignant mesothelioma by estimating the objective response rate (CR and PR) at trial closure

To further characterize the safety profile of ZD1839 at a 250mg daily dose

Secondary outcome:

To estimate PFS (progression free survival)

To estimate overall survival

To estimate duration of response

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: September 2003
Last updated: June 5, 2012

Page last updated: August 23, 2015

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