Iressa Follow-up Trial
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| ClinicalTrials.gov Identifier: NCT00357734 |
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Recruitment Status
:
Completed
First Posted
: July 27, 2006
Results First Posted
: June 23, 2016
Last Update Posted
: August 30, 2016
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer Breast Cancer | Drug: Gefitinib | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 14 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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. |
| Study Start Date : | January 2005 |
| Actual Primary Completion Date : | May 2015 |
| Actual Study Completion Date : | May 2015 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Gefitinib
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Gefitinib (ZD1839)
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
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Drug: Gefitinib
ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
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Primary Outcome Measures
:
- 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) ]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) 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) ]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 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) ]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 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) ]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.
Secondary Outcome Measures
:
- Progression-free Survival (PFS) [ Time Frame: From randomization until progression or death (up to 120 months) ]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.
- Overall Survival (OS) [ Time Frame: From randomization until death (up to 120 months) ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357734
Locations
| 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, Germany | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Germany Medical Director, MD | AstraZeneca |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00357734 History of Changes |
| Other Study ID Numbers: |
1839IL/0555 D7913L00008 |
| First Posted: | July 27, 2006 Key Record Dates |
| Results First Posted: | June 23, 2016 |
| Last Update Posted: | August 30, 2016 |
| Last Verified: | June 2016 |
Keywords provided by AstraZeneca:
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lung cancer breast cancer |
Additional relevant MeSH terms:
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Gefitinib Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |