Phase 3
Completed N=14
Iressa Follow-up Trial
Source: ClinicalTrials.gov NCT00357734 ↗Enrolled (actual)
14
Serious AEs
28.6%
Results posted
Jun 2016
Primary outcomePrimary: Number of Serious Adverse Events (SAEs) — 13 number of SAEs
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Serious Adverse Events (SAEs) |
13 | — |
| PRIMARY Number of Serious Adverse Events (SAEs) Related to ZD1839 |
— | — |
| PRIMARY Number of Other Adverse Events (AEs) |
40 | — |
| PRIMARY Number of Other Adverse Events (AEs) Related to ZD1839 |
19 | — |
| SECONDARY Progression-free Survival (PFS) |
26.5 | — |
| SECONDARY Overall Survival (OS) |
23.5 | — |
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
Data sourced from ClinicalTrials.gov (NCT00357734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.