Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials.
Overview
- Phase
- Phase 3
- Intervention
- Gefitinib
- Conditions
- Lung Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Number of Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).
Investigators
Eligibility Criteria
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
Arms & Interventions
Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Intervention: Gefitinib
Outcomes
Primary Outcomes
Number of Serious Adverse Events (SAEs)
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (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
Number of Other Adverse Events (AEs)
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (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.
Number of Serious Adverse Events (SAEs) Related to ZD1839
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (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.
Number of Other Adverse Events (AEs) Related to ZD1839
Time Frame: Serious adverse events (SAEs) and non-serious AEs were collected from the start of study treatment until 30 days after the last dose of study treatment or 30 days after last visit (up to approximately 120 months)
Assessment of the long-term safety profile of ZD1839 therapy by assessing the incidence of adverse events. Any adverse events (AEs) and serious adverse events (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.
Secondary Outcomes
- Progression-free Survival (PFS)(From randomization until progression or death (up to 120 months))
- Overall Survival (OS)(From randomization until death (up to 120 months))