search
Back to results

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

Primary Purpose

Non Small Cell Lung Cancer (NSCLC)

Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
ZD1839 (Iressa)
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Non Small Cell Lung Cancer (NSCLC)

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site
  • Research Site

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 21, 2008
Last Updated
September 12, 2018
Sponsor
AstraZeneca
search

1. Study Identification

Unique Protocol Identification Number
NCT00683306
Brief Title
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

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Approved for marketing
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer (NSCLC)

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ZD1839 (Iressa)
Other Intervention Name(s)
Iressa
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuri Rukazenkov
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Research Site
City
Concord
ZIP/Postal Code
2139
Country
Australia
Facility Name
Research Site
City
Graz
ZIP/Postal Code
AT-8306
Country
Austria
Facility Name
Research Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Research Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Research Site
City
Fortaleza
ZIP/Postal Code
:60431-970
Country
Brazil
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
20230-130
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01221-020
Country
Brazil
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01420-000
Country
Brazil
Facility Name
Research Site
City
Sorocaba
ZIP/Postal Code
18030-200
Country
Brazil
Facility Name
Research Site
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1233
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1756
Country
Bulgaria
Facility Name
Research Site
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Research Site
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Research Site
City
Tallinn
ZIP/Postal Code
11619
Country
Estonia
Facility Name
Research Site
City
Tartu
ZIP/Postal Code
51003
Country
Estonia
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1529
Country
Hungary
Facility Name
Research Site
City
Deszk
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Research Site
City
Mosdós
ZIP/Postal Code
7257
Country
Hungary
Facility Name
Research Site
City
Pécs
ZIP/Postal Code
7635
Country
Hungary
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Facility Name
Research Site
City
Hyderabad
ZIP/Postal Code
500082
Country
India
Facility Name
Research Site
City
Karnataka
Country
India
Facility Name
Research Site
City
Kolkata
ZIP/Postal Code
700054
Country
India
Facility Name
Research Site
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Research Site
City
New Delhi
ZIP/Postal Code
110 085
Country
India
Facility Name
Research Site
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Research Site
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Research Site
City
Daugavpils
ZIP/Postal Code
LV-5420
Country
Latvia
Facility Name
Research Site
City
Riga
ZIP/Postal Code
LV-1002
Country
Latvia
Facility Name
Research Site
City
Kuala Lumpur
ZIP/Postal Code
50590
Country
Malaysia
Facility Name
Research Site
City
Nilai
Country
Malaysia
Facility Name
Research Site
City
Penang
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Research Site
City
Penang
ZIP/Postal Code
11200
Country
Malaysia
Facility Name
Research Site
City
Penang
Country
Malaysia
Facility Name
Research Site
City
Durango
ZIP/Postal Code
34037
Country
Mexico
Facility Name
Research Site
City
Mexico Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64320
Country
Mexico
Facility Name
Research Site
City
Torreon
ZIP/Postal Code
27000
Country
Mexico
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Facility Name
Research Site
City
Pasig
Country
Philippines
Facility Name
Research Site
City
Quezon City
ZIP/Postal Code
1104
Country
Philippines
Facility Name
Research Site
City
Quezon City
Country
Philippines
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
022322
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research Site
City
Moscow
ZIP/Postal Code
121356
Country
Russian Federation
Facility Name
Research Site
City
Singapore
ZIP/Postal Code
169610
Country
Singapore
Facility Name
Research Site
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
Facility Name
Research Site
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Research Site
City
Ankara
Country
Turkey
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34030
Country
Turkey
Facility Name
Research Site
City
İstanbul
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Open Label Extension Study With Gefitinib (IRESSA™) for Completing Trial Patients Who May Benefit From Further Treatment

We'll reach out to this number within 24 hrs