Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials
18 Years
N/A
Both
Lung Cancer, Breast Cancer
Trial Information
Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials
Inclusion Criteria:
- Provision of written informed consent to participate in the trial.
- Female or male aged 18 years and over.
- Patients with previously diagnosed cancer who have been treated with ZD1839 in a
parent ZD1839 clinical trial and may benefit from continuation
Exclusion Criteria:
- Known severe hypersensitivity to ZD1839
- Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's
Wort.
- Withdrawal from a parent ZD1839 trial because of tumor progress
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839.
Outcome Description:
Any AEs and SAEs occurring during treatment and any SAEs occurring within 30 days after stopping the trial drug must be followed to resolution unless, in the investigator's opinion, the condition is unlikely to resolve because of the patient's underlying disease
Outcome Time Frame:
Until 30 days after the last dose of trial drug
Safety Issue:
No
Principal Investigator
AstraZeneca Germany Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
1839IL/0555
NCT ID:
NCT00357734
Start Date:
January 2005
Completion Date:
May 2013
Related Keywords:
- Lung Cancer
- Breast Cancer
- lung cancer
- breast cancer
- Breast Neoplasms
- Lung Neoplasms
Name | Location |
|---|
