Iressa Follow-up Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00357734
First received: July 26, 2006
Last updated: July 21, 2016
Last verified: June 2016
Results First Received: May 17, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Lung Cancer
Breast Cancer
Intervention: Drug: Gefitinib

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First subject enrolled: 16 June 2005, Last subject last visit: 18 May 2015. The study was conducted in Germany.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gefitinib (ZD1839) ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Participant Flow:   Overall Study
    Gefitinib (ZD1839)  
STARTED     14  
Patients Received 250 mg of ZD1839     13  
Patient Received 500 mg of ZD1839     1  
COMPLETED     10  
NOT COMPLETED     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gefitinib (ZD1839) ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial

Baseline Measures
    Gefitinib (ZD1839)  
Number of Participants  
[units: participants]
  14  
Age  
[units: Years]
Mean (Full Range)
  66  
  (52 to 81)  
Gender  
[units: Participants]
 
Female     10  
Male     4  



  Outcome Measures
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1.  Primary:   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) ]

2.  Primary:   Number of Seroius 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) ]

3.  Primary:   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) ]

4.  Primary:   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) ]

5.  Secondary:   Progression-free Survival (PFS)   [ Time Frame: From randomization until progression or death (up to 120 months) ]

6.  Secondary:   Overall Survival (OS)   [ Time Frame: From randomization until death (up to 120 months) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was stopped after enrolling 14 of 100 patients. The outcome was biased by the limited number of patients. Therefore, data allow only a limited statement on efficacy and long term safety.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerard Lynch
Organization: AstraZeneca
e-mail: aztrial_results_posting@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00357734     History of Changes
Other Study ID Numbers: 1839IL/0555
D7913L00008
Study First Received: July 26, 2006
Results First Received: May 17, 2016
Last Updated: July 21, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices