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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.

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Official Title

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

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

Iressa Follow-up trial

NCT ID

Therapeutic Area

Research Site

Multicenter open-label, long-term safety trial of treatment extension with ZD1839 in patients who have been treated in other ZD1839 clinical trials.

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

Age Continuous

Gender, Male/Female

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.

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.

Progression-free survival (PFS)

Overall survival (OS)

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)

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.

Iressa Follow-up trial

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator