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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00206219




Registration number
NCT00206219
Ethics application status
Date submitted
16/09/2005
Date registered
21/09/2005
Date last updated
27/01/2011

Titles & IDs
Public title
Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
Scientific title
A Phase III Randomised, Stratified, Parallel-Group, Multi-Centre, Comparative Study of ZD1839 (Iressa®) 250 Mg and 500 Mg Versus Methotrexate for Previously Treated Patients With Squamous Cell Carcinoma of the Head and Neck
Secondary ID [1] 0 0
EudraCT no.2004-002662-38
Secondary ID [2] 0 0
1839IL/0704
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Squamous Cell Carcinoma of the Head and Neck 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Head and neck

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Compare ZD1839 versus methotrexate in overall survival
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
* Histological confirmation of evidence of squamous cell carcinoma of the head and neck.
* Tumors have progressed after primary treatment with radiation or chemoradiation and have failed to respond to at least one course of standard platinum-based chemotherapy.
* Tumors have progressed after primary treatment with radiation or chemoradiation and are considered unsuitable for platinum-based chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Carcinomas of the post-nasal space, thyroid, sinus or salivary gland tumors.
* Isolated recurrent disease that may be amenable to local therapy; e.g., surgical intervention or radiation therapy.
* Known severe hypersensitivity to ZD1839, Methotrexate or any of the excipients of these products.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2007
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Research Site - Westmead
Recruitment postcode(s) [1] 0 0
- Westmead
Recruitment outside Australia
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United States of America
State/province [1] 0 0
Alabama
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Georgia
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Illinois
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Iowa
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Kentucky
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Louisiana
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Maine
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Maryland
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Michigan
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Nebraska
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Wisconsin
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Argentina
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Buenos Aires
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Salta
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Argentina
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Santa Fe
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Belgium
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Brussels (Woluwé-St-Lambert)
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Belgium
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Brussels
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Belgium
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Edegem
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Gent
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Haine-Saint-Paul
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GO
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RJ
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SP
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British Columbia
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Manitoba
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Nova Scotia
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Ontario
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Quebec
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Zagreb
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Brno
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Ostrava - Poruba
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Ostrava
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Praha 2
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Praha 5
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Tallinn
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Bologna
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Pretoria
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Granada
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Santander
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Valencia
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Álava
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Göteborg
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Sweden
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Malmö
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Sweden
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Stockholm
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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United Kingdom
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Leeds
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United Kingdom
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London

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
AstraZeneca Iressa Medical Science Director, MD
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00206219