Clinical trial NCT00683306: Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Official title: Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Non Small Cell Lung Cancer (NSCLC)
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-05-23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide gefitinib treatment to patients who, on completion or closure of other gefitinib clinical studies, were either receiving placebo treatment, or are continuing on the same dose and regimen of gefitinib established in their preceding study, for as long as the patients continue to derive benefit.


Eligibility criteria: Inclusion Criteria:

* Patients who have completed preceding gefitinib therapy from either the 1839IL/0709 (250mg dosing) study or 1839IL/0710 (250mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
* No more than 14 days lapse in gefitinib treatment between the patient completing the preceding gefitinib clinical study and beginning of this study except when agreed by the AstraZeneca physician.

Exclusion Criteria:

* Any evidence of clinically active interstitial lung disease (patients with chronic,stable, radiographic changes who are asymptomatic need not be excluded).
* In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease).
* Withdrawal, at any time, from the preceding gefitinib study.
* Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John's Wort

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Research Site
city: Concord
country: Australia
facility: Research Site
city: Graz
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Wien
country: Austria
facility: Research Site
city: Fortaleza
country: Brazil
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sao Paulo
country: Brazil
facility: Research Site
city: Sorocaba
country: Brazil
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Veliko Tarnovo
country: Bulgaria
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Deszk
country: Hungary
facility: Research Site
city: Mosdós
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Zalaegerszeg
country: Hungary
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
city: Karnataka
country: India
facility: Research Site
city: Kolkata
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Vellore
country: India
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Nilai
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Penang
country: Malaysia
facility: Research Site
city: Durango
country: Mexico
facility: Research Site
city: Mexico Distrito Federal
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Torreon
country: Mexico
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Pasig
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Singapore
country: Singapore
facility: Research Site
city: Johannesburg
country: South Africa
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Tao-Yuan
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Chiang Mai
country: Thailand
facility: Research Site
city: Ankara
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: İstanbul
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Yuri Rukazenkov
role: STUDY_DIRECTOR
References: