Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment
Multicentre, Open Label, Extension Study of Treatment With Gefitinib(IRESSA™) for Patients Completing Other Gefitinib Clinical Studies Who May Benefit From Gefitinib Treatment
1 other identifier
expanded_access
N/A
18 countries
62
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 Health
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62 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2008
CompletedFirst Posted
Study publicly available on registry
May 23, 2008
CompletedSeptember 13, 2018
August 1, 2018
May 21, 2008
September 12, 2018
Conditions
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (65)
Research Site
La Plata, 1900, Argentina
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Concord, 2139, Australia
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Graz, AT-8306, Austria
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Linz, 4020, Austria
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Vienna, 1140, Austria
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Fortaleza, :60431-970, Brazil
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Porto Alegre, 90610-000, Brazil
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Rio de Janeiro, 20230-130, Brazil
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São Paulo, 01221-020, Brazil
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São Paulo, 01420-000, Brazil
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Sorocaba, 18030-200, Brazil
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Plovdiv, 4000, Bulgaria
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Sofia, 1233, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1756, Bulgaria
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Varna, 9000, Bulgaria
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Veliko Tarnovo, 5000, Bulgaria
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Tallinn, 11619, Estonia
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Tartu, 51003, Estonia
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Budapest, 1529, Hungary
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Deszk, 6772, Hungary
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Mosdós, 7257, Hungary
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Pécs, 7635, Hungary
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Zalaegerszeg, 8900, Hungary
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Hyderabad, 500082, India
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Karnataka, India
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Kolkata, 700054, India
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Mumbai, 400012, India
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New Delhi, 110 085, India
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Pune, 411001, India
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Vellore, 632004, India
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Daugavpils, LV-5420, Latvia
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Riga, LV-1002, Latvia
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George Town, 10990, Malaysia
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George Town, 11200, Malaysia
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George Town, Malaysia
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Kampung Baharu Nilai, Malaysia
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Kuala Lumpur, 50590, Malaysia
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Durango, 34037, Mexico
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Mexico City, 06720, Mexico
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Monterrey, 64320, Mexico
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Torreón, 27000, Mexico
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Manila, 1000, Philippines
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Pasig, Philippines
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Quezon City, 1104, Philippines
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Quezon City, Philippines
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Bucharest, 022322, Romania
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Iași, Romania
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Moscow, 115478, Russia
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Moscow, 121356, Russia
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Singapore, 169610, Singapore
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Johannesburg, 2193, South Africa
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Kaohsiung City, 807, Taiwan
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Taichung, 40705, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taipei, 11490, Taiwan
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Taipei, Taiwan
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Taoyuan District, 333, Taiwan
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Bangkok, 10400, Thailand
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Chiang Mai, 50200, Thailand
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Ankara, Turkey (Türkiye)
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Istanbul, 34030, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yuri Rukazenkov
AstraZeneca
Study Design
- Study Type
- expanded access
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 21, 2008
First Posted
May 23, 2008
Last Updated
September 13, 2018
Record last verified: 2018-08