Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kentucky
Country [11] 0 0
United States of America
State/province [11] 0 0
Louisiana
Country [12] 0 0
United States of America
State/province [12] 0 0
Maine
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New York
Country [18] 0 0
United States of America
State/province [18] 0 0
Oklahoma
Country [19] 0 0
United States of America
State/province [19] 0 0
Pennsylvania
Country [20] 0 0
United States of America
State/province [20] 0 0
Virginia
Country [21] 0 0
United States of America
State/province [21] 0 0
Washington
Country [22] 0 0
United States of America
State/province [22] 0 0
Wisconsin
Country [23] 0 0
Argentina
State/province [23] 0 0
Buenos Aires
Country [24] 0 0
Argentina
State/province [24] 0 0
Salta
Country [25] 0 0
Argentina
State/province [25] 0 0
Santa Fe
Country [26] 0 0
Belgium
State/province [26] 0 0
Brussels (Woluwé-St-Lambert)
Country [27] 0 0
Belgium
State/province [27] 0 0
Brussels
Country [28] 0 0
Belgium
State/province [28] 0 0
Edegem
Country [29] 0 0
Belgium
State/province [29] 0 0
Gent
Country [30] 0 0
Belgium
State/province [30] 0 0
Haine-Saint-Paul
Country [31] 0 0
Brazil
State/province [31] 0 0
GO
Country [32] 0 0
Brazil
State/province [32] 0 0
RJ
Country [33] 0 0
Brazil
State/province [33] 0 0
SP
Country [34] 0 0
Canada
State/province [34] 0 0
British Columbia
Country [35] 0 0
Canada
State/province [35] 0 0
Manitoba
Country [36] 0 0
Canada
State/province [36] 0 0
Nova Scotia
Country [37] 0 0
Canada
State/province [37] 0 0
Ontario
Country [38] 0 0
Canada
State/province [38] 0 0
Quebec
Country [39] 0 0
Croatia
State/province [39] 0 0
Zagreb
Country [40] 0 0
Czech Republic
State/province [40] 0 0
Brno
Country [41] 0 0
Czech Republic
State/province [41] 0 0
Ostrava - Poruba
Country [42] 0 0
Czech Republic
State/province [42] 0 0
Ostrava
Country [43] 0 0
Czech Republic
State/province [43] 0 0
Praha 2
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Praha 5
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Praha 8
Country [46] 0 0
Estonia
State/province [46] 0 0
Tallinn
Country [47] 0 0
Estonia
State/province [47] 0 0
Tartu
Country [48] 0 0
Greece
State/province [48] 0 0
Thessaloniki
Country [49] 0 0
India
State/province [49] 0 0
Kerala
Country [50] 0 0
India
State/province [50] 0 0
Madhya Pradesh
Country [51] 0 0
India
State/province [51] 0 0
Maharashtra
Country [52] 0 0
India
State/province [52] 0 0
New Dehli
Country [53] 0 0
India
State/province [53] 0 0
Rajasthan
Country [54] 0 0
India
State/province [54] 0 0
West Bengal
Country [55] 0 0
Israel
State/province [55] 0 0
Petach Tikva
Country [56] 0 0
Israel
State/province [56] 0 0
Tel-Hashomer
Country [57] 0 0
Italy
State/province [57] 0 0
Bologna
Country [58] 0 0
Italy
State/province [58] 0 0
Cuneo
Country [59] 0 0
Italy
State/province [59] 0 0
Forli'
Country [60] 0 0
Italy
State/province [60] 0 0
Genova
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
Country [62] 0 0
Italy
State/province [62] 0 0
Napoli
Country [63] 0 0
Italy
State/province [63] 0 0
Roma
Country [64] 0 0
Italy
State/province [64] 0 0
Torino
Country [65] 0 0
Latvia
State/province [65] 0 0
Riga
Country [66] 0 0
Lithuania
State/province [66] 0 0
Klaipeda
Country [67] 0 0
Lithuania
State/province [67] 0 0
Vilnius
Country [68] 0 0
Malaysia
State/province [68] 0 0
Nilai
Country [69] 0 0
Malaysia
State/province [69] 0 0
Petaling Jaya
Country [70] 0 0
Netherlands
State/province [70] 0 0
Amsterdam
Country [71] 0 0
Netherlands
State/province [71] 0 0
Maastricht
Country [72] 0 0
Netherlands
State/province [72] 0 0
Nijmegen
Country [73] 0 0
Netherlands
State/province [73] 0 0
Utrecht
Country [74] 0 0
Norway
State/province [74] 0 0
Oslo
Country [75] 0 0
Russian Federation
State/province [75] 0 0
Krasnogorsk
Country [76] 0 0
Russian Federation
State/province [76] 0 0
Moscow
Country [77] 0 0
Russian Federation
State/province [77] 0 0
St.Petersburg
Country [78] 0 0
Slovenia
State/province [78] 0 0
Ljubljana
Country [79] 0 0
South Africa
State/province [79] 0 0
Bloemfontein
Country [80] 0 0
South Africa
State/province [80] 0 0
Cape Town
Country [81] 0 0
South Africa
State/province [81] 0 0
Durban
Country [82] 0 0
South Africa
State/province [82] 0 0
Johannesburg
Country [83] 0 0
South Africa
State/province [83] 0 0
Pretoria
Country [84] 0 0
South Africa
State/province [84] 0 0
Tygerberg
Country [85] 0 0
Spain
State/province [85] 0 0
A Coruña
Country [86] 0 0
Spain
State/province [86] 0 0
Madrid
Country [87] 0 0
Spain
State/province [87] 0 0
Vizcaya
Country [88] 0 0
Spain
State/province [88] 0 0
Granada
Country [89] 0 0
Spain
State/province [89] 0 0
Pontevedra
Country [90] 0 0
Spain
State/province [90] 0 0
Santander
Country [91] 0 0
Spain
State/province [91] 0 0
Valencia
Country [92] 0 0
Spain
State/province [92] 0 0
Álava
Country [93] 0 0
Sweden
State/province [93] 0 0
Göteborg
Country [94] 0 0
Sweden
State/province [94] 0 0
Malmö
Country [95] 0 0
Sweden
State/province [95] 0 0
Stockholm
Country [96] 0 0
Thailand
State/province [96] 0 0
Bangkok
Country [97] 0 0
Thailand
State/province [97] 0 0
Chiang Mai
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Leeds
Country [99] 0 0
United Kingdom
State/province [99] 0 0
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