Head and Neck Phase III Iressa Versus Methotrexate Refractory: Iressa Versus Methotrexate (IMEX)
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
2 other identifiers
interventional
477
24 countries
107
Brief Summary
This study is to compare ZD1839 (250mg and 500mg) versus methotrexate in head and neck cancer in terms of overall survival.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2003
Typical duration for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedJanuary 27, 2011
January 1, 2011
3.8 years
September 16, 2005
January 25, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Compare ZD1839 versus methotrexate in overall survival
Secondary Outcomes (1)
Compare ZD1839 versus methotrexate in symptom improvement, tumor response, safety and tolerability and quality of life - assessed throughout the study.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (109)
Research Site
Birmingham, Alabama, United States
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Tucson, Arizona, United States
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Palm Springs, California, United States
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Aurora, Colorado, United States
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New Haven, Connecticut, United States
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Norwalk, Connecticut, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Ormand Beach, Florida, United States
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Savannah, Georgia, United States
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Chicago, Illinois, United States
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Des Moines, Iowa, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Waterville, Maine, United States
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Bethesda, Maryland, United States
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Detroit, Michigan, United States
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Omaha, Nebraska, United States
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Hackensack, New Jersey, United States
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Brooklyn, New York, United States
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New York, New York, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Norfolk, Virginia, United States
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Olympia, Washington, United States
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Milwaukee, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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El Palomar, Buenos Aires, Argentina
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Salta, Salta Province, Argentina
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Santa Fe, Santa Fe Province, Argentina
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Westmead, New South Wales, Australia
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Brussels, Belgium
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Brussels (Woluwé-St-Lambert), Belgium
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Edegem, Belgium
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Ghent, Belgium
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Haine-Saint-Paul, Belgium
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Goiânia, Goiás, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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São Paulo, São Paulo, Brazil
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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London, Ontario, Canada
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Windsor, Ontario, Canada
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Montreal, Quebec, Canada
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Zagreb, Croatia
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Brno, Czechia
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Ostrava, Czechia
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Ostrava - Poruba, Czechia
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Prague, Czechia
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Tallinn, Estonia
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Tartu, Estonia
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Thessaloniki, Greece
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Kochi, Kerala, India
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Thiruvananthapuram, Kerala, India
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Bhopal, Madhya Pradesh, India
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Pune, Maharashtra, India
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Ansārinagar, New Dehli, India
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Jaipur, Rajasthan, India
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Kolkata, West Bengal, India
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New Dehli, India
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Petah Tikva, Israel
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Tel Litwinsky, Israel
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Bologna, Italy
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Cuneo, Italy
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Forlì, Italy
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Genova, Italy
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Milan, Italy
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Napoli, Italy
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Roma, Italy
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Torino, Italy
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Riga, Latvia
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Klaipėda, Lithuania
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Vilnius, Lithuania
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Kampung Baharu Nilai, Malaysia
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Petaling Jaya, Malaysia
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Amsterdam, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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Utrecht, Netherlands
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Oslo, Norway
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Krasnogorsk, Russia
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Moscow, Russia
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Saint Petersburg, Russia
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Zaloska, Ljubljana, Slovenia
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Ljubljana, Slovenia
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Bloemfontein, South Africa
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Pretoria, South Africa
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Tygerberg, South Africa
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Santiago de Compostela, A Coruña, Spain
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Granada, Granada, Spain
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Leganés, Madrid, Spain
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Madrid, Madrid, Spain
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Pontevedra, Pontevedra, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Santander, Spain
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Valencia, Spain
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Vitoria-Gasteiz, Álava, Spain
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Gothenburg, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Bangkok, Thailand
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Chiang Mai, Thailand
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Leeds, United Kingdom
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London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca Iressa Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 21, 2005
Study Start
November 1, 2003
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
January 27, 2011
Record last verified: 2011-01