Clinical trial NCT00357734: Iressa Follow-up Trial
Official title: Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lung Cancer
Breast Cancer
Keywords: lung cancer
breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-07-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of Serious Adverse Events (SAEs)
timeFrame: 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)
measure: Number of Serious Adverse Events (SAEs) Related to ZD1839
timeFrame: 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)
measure: Number of Other Adverse Events (AEs)
timeFrame: 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)
measure: Number of Other Adverse Events (AEs) Related to ZD1839
timeFrame: 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)
Secondary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: From randomization until progression or death (up to 120 months)
measure: Overall Survival (OS)
timeFrame: From randomization until death (up to 120 months)
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Research Site
city: Gauting
country: Germany
facility: Research Site
city: Großhansdorf
country: Germany
facility: Research Site
city: Hemer
country: Germany
facility: Research Site
city: Jena
country: Germany
facility: Research Site
city: Minden
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director, MD
role: STUDY_DIRECTOR
References: