Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
192 participants
INTERVENTIONAL
2004-07-31
2006-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
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Gefitinib
Vinorelbine
Eligibility Criteria
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Inclusion Criteria
* NSCLC - locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy chemonaïve, life expectancy of 12 weeks
* WHO Performance status \<= 2
Exclusion Criteria
* Less than 4 weeks since completion of radiotherapy or persistence of any radiotherapy related toxicity.
* Hypersensitivity to ZD1839 or intravenous vinorelbine
* Prior treatment with EGFR inhibitors
* Other co-existing malignancies
* ALT/AST \>2.5 x ULRR
* ANC \< 2.0 x 10\^9/L or platelets \< 100 x 10\^9/L
70 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Iressa Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
St Leonards, New South Wales, Australia
Research Site
Westmead, New South Wales, Australia
Research Site
South Brisbane, Queensland, Australia
Research Site
Nedlands, Western Australia, Australia
Research Site
Victoria, , Australia
Research Site
Fortaleza, Ceará, Brazil
Research Site
Goiânia, Goiás, Brazil
Research Site
Rio de Janeiro, Rio de Janeiro, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Prague, CZ, Czechia
Research Site
Ústí nad Labem, CZ, Czechia
Research Site
Hradec Králové, , Czechia
Research Site
Kutná Hora, , Czechia
Research Site
Olomouc, , Czechia
Research Site
Ostrava, , Czechia
Research Site
Ostrava - Poruba, , Czechia
Research Site
Pilsen, , Czechia
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Marseille, , France
Research Site
Montpellier, , France
Research Site
Pierre-Bénite, , France
Research Site
Vesoul, , France
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Heidelberg, Baden-Wurttemberg, Germany
Research Site
Ulm, Baden-Wurttemberg, Germany
Research Site
München, Bavaria, Germany
Research Site
Hamburg, City state of Hamburg, Germany
Research Site
Magdeburg, Saxony-Anhalt, Germany
Research Site
Bad Segeberg, Schleswig-Holstein, Germany
Research Site
Berlin, State of Berlin, Germany
Research Site
Großhansdorf, , Germany
Research Site
Halle, , Germany
Research Site
Mainz, , Germany
Research Site
La Torretta, Ancona, Italy
Research Site
Bergamo, BG, Italy
Research Site
Bologna, BO, Italy
Research Site
Catania, CT, Italy
Research Site
Melegnano, MI, Italy
Research Site
Milan, MI, Italy
Research Site
Rozzano, MI, Italy
Research Site
Modena, MO, Italy
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Parma, PR, Italy
Research Site
Orbassano, TO, Italy
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Torino, TO, Italy
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Napoli, , Italy
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Cape Town, , South Africa
Research Site
Durban, , South Africa
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Seoul, , South Korea
Research Site
Taichung, , Taiwan
Research Site
Taipei, , Taiwan
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Cambridge, Cambrideshire, United Kingdom
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Birmingham, West Midlands, United Kingdom
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Aberdeen, , United Kingdom
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Dundee, , United Kingdom
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Glasgow, , United Kingdom
Research Site
Nottingham, , United Kingdom
Research Site
Sheffield, , United Kingdom
Countries
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References
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Crino L, Cappuzzo F, Zatloukal P, Reck M, Pesek M, Thompson JC, Ford HE, Hirsch FR, Varella-Garcia M, Ghiorghiu S, Duffield EL, Armour AA, Speake G, Cullen M. Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study. J Clin Oncol. 2008 Sep 10;26(26):4253-60. doi: 10.1200/JCO.2007.15.0672.
Other Identifiers
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INVITE
Identifier Type: -
Identifier Source: secondary_id
D791AC00001
Identifier Type: -
Identifier Source: org_study_id
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