Iressa Follow-up Trial

Breast Cancer Clinical 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357734
• Other study ID #: 1839IL/0555
• Secondary ID: D7913L00008
• Status: Completed
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: August 29, 2016
• Start date: January 2005
• Est. completion date: May 2015

Study information

• Verified date: June 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• Gefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Locations

Country	Name	City	State
Germany	Research Site	Freiburg
Germany	Research Site	Gauting
Germany	Research Site	Großhansdorf
Germany	Research Site	Hemer
Germany	Research Site	Jena
Germany	Research Site	Minden
Germany	Research Site	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Serious Adverse Events (SAEs)	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	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)	No
Primary	Number of Serious Adverse Events (SAEs) Related to ZD1839	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.	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)	No
Primary	Number of Other Adverse Events (AEs)	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.	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)	No
Primary	Number of Other Adverse Events (AEs) Related to ZD1839	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.	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)	No
Secondary	Progression-free Survival (PFS)	Objective disease progressing was assessed using the previous cancer response criteria in the parent ZD1839 trial: ie Southwest Oncology Group (SWOG) tumor response criteria, as a 50% increase or an increase of 10 cm2 (whichever is smaller) in the sum of products of all measurable lesions from the overall smallest sum observed (over baseline if no decrease) using the same techniques as baseline; Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase In the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	From randomization until progression or death (up to 120 months)	No
Secondary	Overall Survival (OS)		From randomization until death (up to 120 months)	No