Back to resultsAn Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
Primary Purpose
Non Small Cell Lung Cancer, Cancer of the Head and Neck
Status
Approved for marketing
Phase
Locations
International
Study Type
Expanded Access
Intervention
ZD1839
Sponsored by
About this trial
This is an expanded access trial for Non Small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Have received at least one course of standard systemic chemotherapy or radiation therapy
- Are ineligible for chemotherapy or radiotherapy
- Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC
- Are, in the investigators opinion, not medically suitable for chemotherapy.
Exclusion Criteria:
- Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
- Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
- Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
- Incomplete healing from prior oncologic or other major surgery
Sites / Locations
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Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00684385
Brief Title
An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
Official Title
An International Expanded Access Clinical Programme With ZD1839 (IRESSA) for Patients With Advanced Non-small Cell Lung Cancer(NSCLC) and Patients With Recurrent or Metastatic or Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck (H&NC)
Study Type
Expanded Access
2. Study Status
Record Verification Date
February 2019
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 ZD1839 for those patients with locally advanced and/or metastatic non-operable non-small cell lung cancer (stage III or IV) or recurrent and/or metastatic squamous cell head and neck cancer who receive the therapy on an expanded access basis due to their inability to meet eligibility criteria for on-going recruiting trials, inability to participate in other clinical trials (e.g., poor performance status, lack of geographic proximity), or because other medical interventions are not considered appropriate or acceptable.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Cancer of the Head and Neck
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
ZD1839
Other Intervention Name(s)
Iressa
Intervention Description
250mg administered daily for patients with NSCLC and500mg daily for patients with H&NC. Treatment dispensed to patients on Day 1 and every 12 weeks thereafter until the patient withdraws. Patients with NSCLC will take one tablet at each dose administration; patients with squamous cell H&NC will take two tablets at each dose administration.
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:
Have received at least one course of standard systemic chemotherapy or radiation therapy
Are ineligible for chemotherapy or radiotherapy
Are ineligible or not candidates for enrollment in available ZD1839 trials for NSCLC or squamous cell H&NC
Are, in the investigators opinion, not medically suitable for chemotherapy.
Exclusion Criteria:
Current eligibility (i.e., meeting the inclusion and exclusion criteria except signed informed consent) for any ZD1839 protocol available to the patient, or previous enrollment in a blinded ZD1839 protocol
Patients from a blinded protocol may be considered for acceptance, with AstraZeneca's permission, only after trial completion and unblinding of all patients.
Patients eligible for or previously enrolled in an open-label or unblinded ZD1839 clinical trial may be considered for acceptance with AstraZeneca's permission
Incomplete healing from prior oncologic or other major surgery
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
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
13189
Country
Germany
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Research Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Research Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Research Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Research Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Facility Name
Research Site
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06112
Country
Germany
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Research Site
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Research Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Research Site
City
Laatzen
ZIP/Postal Code
30880
Country
Germany
Facility Name
Research Site
City
Lemgo
ZIP/Postal Code
32657
Country
Germany
Facility Name
Research Site
City
Löwenstein
ZIP/Postal Code
74245
Country
Germany
Facility Name
Research Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Research Site
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Research Site
City
Nürnberg
ZIP/Postal Code
90419
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Research Site
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Research Site
City
Stralsund
ZIP/Postal Code
18437
Country
Germany
Facility Name
Research Site
City
Stuttgart
ZIP/Postal Code
70174
Country
Germany
Facility Name
Research Site
City
Trier
ZIP/Postal Code
54292
Country
Germany
Facility Name
Research Site
City
Wiesbaden
ZIP/Postal Code
65199
Country
Germany
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1121
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Research Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Facility Name
Research Site
City
Törökbálint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Research Site
City
Gdańsk
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Research Site
City
Zabrze
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Research Site
City
Newcastle-upon-Tyne
ZIP/Postal Code
NE4 5BE
Country
United Kingdom
12. IPD Sharing Statement
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An Expanded Access Programme With Iressa for Patients With Non-Small-Cell Lung Cancer and Cancer of the Head and Neck
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