Iressa Follow-up Trial

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00357734
First received: July 26, 2006
Last updated: October 14, 2014
Last verified: October 2014

July 26, 2006
October 14, 2014
January 2005
December 2014   (final data collection date for primary outcome measure)
To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839. [ Time Frame: Until 30 days after the last dose of trial drug ] [ Designated as safety issue: No ]
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
To assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839.
Complete list of historical versions of study NCT00357734 on ClinicalTrials.gov Archive Site
To estimate clinical benefit of ZD1839 therapy by assessing progression free survival and overall survival. [ Time Frame: Every 3 months until death of last patient ] [ Designated as safety issue: No ]
Patients are followed for progression and overall survival
To estimate clinical benefit of ZD1839 therapy by assessing progression free survival and overall survival.
Not Provided
Not Provided
 
Iressa Follow-up Trial
Multicenter Open-label, Long-term Safety Trial of Treatment Extension With ZD1839 in Patients Who Have Been Treated in Other ZD1839 Clinical Trials

The purpose of this study is to assess the long-term safety profile and the secondary objective to estimate clinical benefit of ZD1839 (gefitinib).

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lung Cancer
  • Breast Cancer
Drug: Gefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Experimental: Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
Intervention: Drug: Gefitinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
14
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00357734
1839IL/0555, D7913L00008
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: AstraZeneca Germany Medical Director, MD AstraZeneca
AstraZeneca
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP