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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00683306




Registration number
NCT00683306
Ethics application status
Date submitted
21/05/2008
Date registered
23/05/2008
Date last updated
13/09/2018

Titles & IDs
Public title
Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Scientific title
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
Secondary ID [1] 0 0
D791AC00008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer (NSCLC) 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Expanded Access
Description of intervention(s) / exposure
Treatment: Drugs - ZD1839 (Iressa)

Treatment: Drugs: ZD1839 (Iressa)
Gefitinib supplied for oral use at the dose and schedule that the patient received in the previous gefitinib clinical study. In the case of placebo patients, the gefitinib dose will be as described in the protocol of their previous gefitinib clinical study.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
130 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Approved for marketing
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Concord
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
La Plata
Country [2] 0 0
Austria
State/province [2] 0 0
Graz
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Brazil
State/province [5] 0 0
Fortaleza
Country [6] 0 0
Brazil
State/province [6] 0 0
Porto Alegre
Country [7] 0 0
Brazil
State/province [7] 0 0
Rio de Janeiro
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Brazil
State/province [9] 0 0
Sorocaba
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Plovdiv
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Sofia
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Varna
Country [13] 0 0
Bulgaria
State/province [13] 0 0
Veliko Tarnovo
Country [14] 0 0
Estonia
State/province [14] 0 0
Tallinn
Country [15] 0 0
Estonia
State/province [15] 0 0
Tartu
Country [16] 0 0
Hungary
State/province [16] 0 0
Budapest
Country [17] 0 0
Hungary
State/province [17] 0 0
Deszk
Country [18] 0 0
Hungary
State/province [18] 0 0
Mosdós
Country [19] 0 0
Hungary
State/province [19] 0 0
Pécs
Country [20] 0 0
Hungary
State/province [20] 0 0
Zalaegerszeg
Country [21] 0 0
India
State/province [21] 0 0
Hyderabad
Country [22] 0 0
India
State/province [22] 0 0
Karnataka
Country [23] 0 0
India
State/province [23] 0 0
Kolkata
Country [24] 0 0
India
State/province [24] 0 0
Mumbai
Country [25] 0 0
India
State/province [25] 0 0
New Delhi
Country [26] 0 0
India
State/province [26] 0 0
Pune
Country [27] 0 0
India
State/province [27] 0 0
Vellore
Country [28] 0 0
Latvia
State/province [28] 0 0
Daugavpils
Country [29] 0 0
Latvia
State/province [29] 0 0
Riga
Country [30] 0 0
Malaysia
State/province [30] 0 0
Kuala Lumpur
Country [31] 0 0
Malaysia
State/province [31] 0 0
Nilai
Country [32] 0 0
Malaysia
State/province [32] 0 0
Penang
Country [33] 0 0
Mexico
State/province [33] 0 0
Durango
Country [34] 0 0
Mexico
State/province [34] 0 0
Mexico Distrito Federal
Country [35] 0 0
Mexico
State/province [35] 0 0
Monterrey
Country [36] 0 0
Mexico
State/province [36] 0 0
Torreon
Country [37] 0 0
Philippines
State/province [37] 0 0
Manila
Country [38] 0 0
Philippines
State/province [38] 0 0
Pasig
Country [39] 0 0
Philippines
State/province [39] 0 0
Quezon City
Country [40] 0 0
Romania
State/province [40] 0 0
Bucharest
Country [41] 0 0
Romania
State/province [41] 0 0
Iasi
Country [42] 0 0
Russian Federation
State/province [42] 0 0
Moscow
Country [43] 0 0
Singapore
State/province [43] 0 0
Singapore
Country [44] 0 0
South Africa
State/province [44] 0 0
Johannesburg
Country [45] 0 0
Taiwan
State/province [45] 0 0
Kaohsiung
Country [46] 0 0
Taiwan
State/province [46] 0 0
Taichung
Country [47] 0 0
Taiwan
State/province [47] 0 0
Tainan
Country [48] 0 0
Taiwan
State/province [48] 0 0
Taipei
Country [49] 0 0
Taiwan
State/province [49] 0 0
Tao-Yuan
Country [50] 0 0
Thailand
State/province [50] 0 0
Bangkok
Country [51] 0 0
Thailand
State/province [51] 0 0
Chiang Mai
Country [52] 0 0
Turkey
State/province [52] 0 0
Ankara
Country [53] 0 0
Turkey
State/province [53] 0 0
Istanbul

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00683306
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Yuri Rukazenkov
Address 0 0
AstraZeneca
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00683306