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| ID | Type | Description | Link |
|---|---|---|---|
| D7913C00711 |
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The purpose of the study is to determine if the addition of Iressa to Best Supportive Care treatment will increase the progression free survival of chemo-naïve, poor performance status patients, with stage IIIB or IV NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gefitinib | Experimental | ZD1839 + BSC (best supportive care) |
|
| Placebo | Placebo Comparator | Placebo + BSC (best supportive care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gefitinib | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| To compare Iressa v best supportive care in terms of progression free survival | Progression-free survival |
| Measure | Description | Time Frame |
|---|---|---|
| To compare Iressa v best supportive care in terms of objective tumour response rate | Overall objective tumour response rate (CR and PR) according to the RECIST criteria | |
| To compare Iressa v best supportive care in terms of overall survival | Time to death |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the correlation of the expression of biomarkers in tumour tissue obtained prior to gefitinib therapy with gefitinib clinical efficacy and to determine a set of biomarkers to enable patient selection for therapy. | Efficacy (objective response rate and progression free survival), toxicity, EGFR signalling pathways markers, RNA expression profile, gene polymorphisms of pre specified germline and tumour genes, DNA methylation, plasma and urine proteomics |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Iressa Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Bedford Park | Australia | ||||
| Research Site |
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| Label | URL |
|---|---|
| CSR-1839IL-0711.pdf | View source |
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|
| To compare Iressa v best supportive care in terms of quality of life | Improvement in patient-reported functionality as measured by trial outcome index, comprised of the physical and functional well being sections and LCS of FACT-L and quality of life measured by the FACT-L total score |
| To compare Iressa v best supportive care in terms of tolerability | Adverse event profile (type, frequency and severity of adverse events); laboratory parameters and vital signs |
| To compare gefitinib + BSC versus Placebo + BSC in terms of Health Resource Utilisation | The use of selected items of resource and concomitant medications including: number of in patient days, number of out patient visits, number of invasive procedures, pallative radiotherapy, concomitant medications. |
| To compare gefitinib + BSC versus Placebo + BSC in terms of changes in pain and fatigue | Changes in pain and fatigue as measured by the single items from the FACT-L physical well being domain. |
| Chermside |
| Australia |
| Research Site | Concord | Australia |
| Research Site | Melbourne | Australia |
| Research Site | Newcastle | Australia |
| Research Site | Prahran | Australia |
| Research Site | Randwick | Australia |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Kelowna | British Columbia | Canada |
| Research Site | Surrey | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Moncton | New Brunswick | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Barrie | Ontario | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Newmarket | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Ottawa | Ontario | Canada |
| Research Site | Sault Ste. Marie | Ontario | Canada |
| Research Site | Thunder Bay | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Nová Ves pod Pleší | Czechia |
| Research Site | 's-Hertogenbosch | Netherlands |
| Research Site | Amsterdam | Netherlands |
| Research Site | Eindhoven | Netherlands |
| Research Site | The Hague | Netherlands |
| Research Site | Zutphen | Netherlands |
| Research Site | Abergavenny | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Cardiff | United Kingdom |
| Research Site | Leeds | United Kingdom |
| Research Site | Wolverhampton | United Kingdom |
| ID | Term |
|---|---|
| D000077156 | Gefitinib |
| ID | Term |
|---|---|
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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