LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Boehringer Ingelheim
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01345669
First received: April 28, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.


Condition Intervention Phase
Head and Neck Neoplasms
Drug: Placebo
Drug: Afatinib
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Afatinib (BIBW 2992) as Adjuvant Therapy After Chemo-radiotherapy in Primary Unresected Patients With Stage III, IVa, or IVb Loco-regionally Advanced Head and Neck Squamous Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Disease Free Survival (DFS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease Free Survival (DFS) rate at 2 years [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall Survival (OS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
  • Health Related Quality of Life (HRQOL) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 669
Study Start Date: October 2011
Estimated Study Completion Date: May 2019
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Afatinib (BIBW 2992)
Once daily
Drug: Afatinib
Once daily
Placebo Comparator: Placebo
Once daily
Drug: Placebo
Once daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
  2. Unresected tumour prior to chemo-radiotherapy (CRT)
  3. Concomitant CRT completed prior to randomisation
  4. After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
  5. Eastern cooperative oncology group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
  2. Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
  3. Any other malignancy (except for simultaneous HNSCC primaries, appropriately treated superficial basal cell skin cancer and surgically cured cervical cancer in situ) unless free of disease for at least five years
  4. Known pre-existing Interstitial Lung Disease (ILD)
  5. Pregnancy or breast feeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345669

Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
Locations
United States, Alaska
1200.131.00171 Boehringer Ingelheim Investigational Site Recruiting
Little Rock, Alaska, United States
United States, California
1200.131.00178 Boehringer Ingelheim Investigational Site Recruiting
Los Angeles, California, United States
1200.131.00181 Boehringer Ingelheim Investigational Site Recruiting
Orange, California, United States
United States, Colorado
1200.131.00177 Boehringer Ingelheim Investigational Site Recruiting
Aurora, Colorado, United States
United States, Connecticut
1200.131.00185 Boehringer Ingelheim Investigational Site Recruiting
New Haven, Connecticut, United States
United States, Florida
1200.131.00193 Boehringer Ingelheim Investigational Site Recruiting
Orlando, Florida, United States
United States, Georgia
1200.131.00194 Boehringer Ingelheim Investigational Site Not yet recruiting
Athens, Georgia, United States
United States, Illinois
1200.131.00191 Boehringer Ingelheim Investigational Site Recruiting
Harvey, Illinois, United States
United States, Louisiana
1200.131.00187 Boehringer Ingelheim Investigational Site Recruiting
New Orleans, Louisiana, United States
United States, Maryland
1200.131.00173 Boehringer Ingelheim Investigational Site Recruiting
Baltimore, Maryland, United States
United States, Massachusetts
1200.131.00176 Boehringer Ingelheim Investigational Site Recruiting
Boston, Massachusetts, United States
1200.131.00190 Boehringer Ingelheim Investigational Site Recruiting
Boston, Massachusetts, United States
United States, Nebraska
1200.131.00182 Boehringer Ingelheim Investigational Site Recruiting
Omaha, Nebraska, United States
United States, New Hampshire
1200.131.00175 Boehringer Ingelheim Investigational Site Recruiting
Lebanon, New Hampshire, United States
United States, New York
1200.131.00188 Boehringer Ingelheim Investigational Site Recruiting
Bronx, New York, United States
1200.131.00179 Boehringer Ingelheim Investigational Site Recruiting
Stony Brook, New York, United States
United States, Pennsylvania
1200.131.00172 Boehringer Ingelheim Investigational Site Recruiting
Philadelphia, Pennsylvania, United States
United States, Texas
1200.131.00184 Boehringer Ingelheim Investigational Site Terminated
San Antonio, Texas, United States
United States, Washington
1200.131.00183 Boehringer Ingelheim Investigational Site Recruiting
Wenatchee, Washington, United States
Argentina
1200.131.05451 Boehringer Ingelheim Investigational Site Recruiting
Ciudad Autonoma de Buenos Aires, Argentina
1200.131.05457 Boehringer Ingelheim Investigational Site Recruiting
Cordoba, Argentina
1200.131.05456 Boehringer Ingelheim Investigational Site Recruiting
Mendoza, Argentina
1200.131.05458 Boehringer Ingelheim Investigational Site Recruiting
San Miguel de Tucuman, Argentina
1200.131.05452 Boehringer Ingelheim Investigational Site Recruiting
Santa Fe, Argentina
1200.131.05453 Boehringer Ingelheim Investigational Site Recruiting
Villa Dominico, Argentina
Australia, Queensland
1200.131.06151 Boehringer Ingelheim Investigational Site Recruiting
Wooloongabba, Queensland, Australia
Austria
1200.131.04358 Boehringer Ingelheim Investigational Site Recruiting
Innsbruck, Austria
1200.131.04353 Boehringer Ingelheim Investigational Site Recruiting
Leoben, Austria
1200.131.04357 Boehringer Ingelheim Investigational Site Recruiting
Linz, Austria
1200.131.04355 Boehringer Ingelheim Investigational Site Recruiting
Salzburg, Austria
1200.131.04356 Boehringer Ingelheim Investigational Site Recruiting
Wien, Austria
1200.131.04351 Boehringer Ingelheim Investigational Site Recruiting
Wien, Austria
1200.131.04359 Boehringer Ingelheim Investigational Site Recruiting
Wien, Austria
Belgium
1200.131.03259 Boehringer Ingelheim Investigational Site Recruiting
Brussel, Belgium
1200.131.03256 Boehringer Ingelheim Investigational Site Recruiting
Charleroi, Belgium
1200.131.03251 Boehringer Ingelheim Investigational Site Recruiting
Edegem, Belgium
1200.131.03255 Boehringer Ingelheim Investigational Site Recruiting
Hasselt, Belgium
1200.131.03253 Boehringer Ingelheim Investigational Site Recruiting
Kortrijk, Belgium
1200.131.03252 Boehringer Ingelheim Investigational Site Recruiting
Liège, Belgium
1200.131.03254 Boehringer Ingelheim Investigational Site Recruiting
Liège, Belgium
1200.131.03258 Boehringer Ingelheim Investigational Site Recruiting
Namur, Belgium
Brazil
1200.131.05554 Boehringer Ingelheim Investigational Site Recruiting
Barretos, Brazil
1200.131.05555 Boehringer Ingelheim Investigational Site Recruiting
Jau, Brazil
1200.131.05557 Boehringer Ingelheim Investigational Site Recruiting
Passo Fundo, Brazil
1200.131.05553 Boehringer Ingelheim Investigational Site Recruiting
Porto Alegre, Brazil
1200.131.05551 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
1200.131.05556 Boehringer Ingelheim Investigational Site Recruiting
Sao Paulo, Brazil
Canada, British Columbia
1200.131.00152 Boehringer Ingelheim Investigational Site Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
1200.131.00156 Boehringer Ingelheim Investigational Site Recruiting
London, Ontario, Canada
1200.131.00157 Boehringer Ingelheim Investigational Site Not yet recruiting
Toronto, Ontario, Canada
1200.131.00151 Boehringer Ingelheim Investigational Site Recruiting
Windsor, Ontario, Canada
Canada, Quebec
1200.131.00153 Boehringer Ingelheim Investigational Site Recruiting
Montreal, Quebec, Canada
1200.131.00154 Boehringer Ingelheim Investigational Site Terminated
Montreal, Quebec, Canada
1200.131.00155 Boehringer Ingelheim Investigational Site Recruiting
Montreal, Quebec, Canada
Chile
1200.131.05652 Boehringer Ingelheim Investigational Site Recruiting
Vina de Mar, Chile
1200.131.05651 Boehringer Ingelheim Investigational Site Recruiting
Vina del Mar, Chile
Czech Republic
1200.131.04254 Boehringer Ingelheim Investigational Site Recruiting
Brno, Czech Republic
1200.131.04252 Boehringer Ingelheim Investigational Site Recruiting
Olomouc, Czech Republic
1200.131.04253 Boehringer Ingelheim Investigational Site Recruiting
Praha 5, Czech Republic
1200.131.04251 Boehringer Ingelheim Investigational Site Recruiting
Praha 8, Czech Republic
Denmark
1200.131.04551 Boehringer Ingelheim Investigational Site Recruiting
København Ø, Denmark
Egypt
1200.131.02052 Boehringer Ingelheim Investigational Site Not yet recruiting
Alexandria, Egypt
1200.131.02051 Boehringer Ingelheim Investigational Site Not yet recruiting
Cairo, Egypt
1200.131.02053 Boehringer Ingelheim Investigational Site Not yet recruiting
Cairo, Egypt
Finland
1200.131.35856 Boehringer Ingelheim Investigational Site Recruiting
Joensuu, Finland
1200.131.35855 Boehringer Ingelheim Investigational Site Recruiting
Kuopio, Finland
1200.131.35853 Boehringer Ingelheim Investigational Site Recruiting
Oulu, Finland
1200.131.35851 Boehringer Ingelheim Investigational Site Recruiting
Turku, Finland
France
1200.131.03353 Boehringer Ingelheim Investigational Site Recruiting
Le Havre, France
1200.131.03362 Boehringer Ingelheim Investigational Site Recruiting
Marseille Cedex 5, France
1200.131.03359 Boehringer Ingelheim Investigational Site Completed
Nice cedex 2, France
1200.131.03365 Boehringer Ingelheim Investigational Site Recruiting
Orléans Cedex 2, France
1200.131.03355 Boehringer Ingelheim Investigational Site Recruiting
Pierre-Bénite, France
1200.131.03367 Boehringer Ingelheim Investigational Site Recruiting
Rouen, France
1200.131.03370 Boehringer Ingelheim Investigational Site Recruiting
Saint Cloud, France
1200.131.03354 Boehringer Ingelheim Investigational Site Recruiting
Saint Herblain Cedex, France
1200.131.03369 Boehringer Ingelheim Investigational Site Recruiting
Saint Priest en Jarez, France
1200.131.03366 Boehringer Ingelheim Investigational Site Recruiting
Salouel, France
1200.131.03356 Boehringer Ingelheim Investigational Site Recruiting
Tours, France
1200.131.03357 Boehringer Ingelheim Investigational Site Recruiting
Villejuif Cedex, France
Germany
1200.131.04954 Boehringer Ingelheim Investigational Site Recruiting
Essen, Germany
1200.131.04961 Boehringer Ingelheim Investigational Site Recruiting
Freiburg, Germany
1200.131.04953 Boehringer Ingelheim Investigational Site Recruiting
Hannover, Germany
1200.131.04956 Boehringer Ingelheim Investigational Site Recruiting
Jena, Germany
1200.131.04959 Boehringer Ingelheim Investigational Site Recruiting
Kaiserslautern, Germany
1200.131.04951 Boehringer Ingelheim Investigational Site Recruiting
Leipzig, Germany
1200.131.04958 Boehringer Ingelheim Investigational Site Recruiting
München, Germany
1200.131.04957 Boehringer Ingelheim Investigational Site Recruiting
Rostock, Germany
1200.131.04964 Boehringer Ingelheim Investigational Site Recruiting
Trier, Germany
1200.131.04963 Boehringer Ingelheim Investigational Site Recruiting
Ulm, Germany
1200.131.04962 Boehringer Ingelheim Investigational Site Recruiting
Villingen-Schwenningen, Germany
Greece
1200.131.03054 Boehringer Ingelheim Investigational Site Recruiting
Chaidari, Greece
1200.131.03056 Boehringer Ingelheim Investigational Site Recruiting
Marousi, Greece
1200.131.03052 Boehringer Ingelheim Investigational Site Recruiting
Thessaloniki, Greece
Hungary
1200.131.03651 Boehringer Ingelheim Investigational Site Recruiting
Budapest, Hungary
1200.131.03652 Boehringer Ingelheim Investigational Site Recruiting
Budapest, Hungary
1200.131.03656 Boehringer Ingelheim Investigational Site Recruiting
Budpest, Hungary
1200.131.03654 Boehringer Ingelheim Investigational Site Recruiting
Debrecen, Hungary
1200.131.03655 Boehringer Ingelheim Investigational Site Recruiting
Kecskemet, Hungary
1200.131.03653 Boehringer Ingelheim Investigational Site Recruiting
Nyiregyhaza, Hungary
India
1200.131.09171 Boehringer Ingelheim Investigational Site Not yet recruiting
Ahmedabad, India
1200.131.09157 Boehringer Ingelheim Investigational Site Not yet recruiting
Bhubaneshwar, India
1200.131.09152 Boehringer Ingelheim Investigational Site Recruiting
Bikaner, India
1200.131.09163 Boehringer Ingelheim Investigational Site Recruiting
Chennai, India
1200.131.09170 Boehringer Ingelheim Investigational Site Not yet recruiting
Gurgaon, India
1200.131.09169 Boehringer Ingelheim Investigational Site Not yet recruiting
Hyderabad, India
1200.131.09162 Boehringer Ingelheim Investigational Site Not yet recruiting
Madurai, Tamil Nadu, India
1200.131.09154 Boehringer Ingelheim Investigational Site Not yet recruiting
Mumbai, India
1200.131.09155 Boehringer Ingelheim Investigational Site Not yet recruiting
Mumbai, India
1200.131.09151 Boehringer Ingelheim Investigational Site Recruiting
New Delhi, India
1200.131.09164 Boehringer Ingelheim Investigational Site Recruiting
Pune, India
1200.131.09167 Boehringer Ingelheim Investigational Site Recruiting
Pune, India
1200.131.09159 Boehringer Ingelheim Investigational Site Recruiting
Vishakapatnam, India
Israel
1200.131.97251 Boehringer Ingelheim Investigational Site Recruiting
Haifa, Israel
1200.131.97253 Boehringer Ingelheim Investigational Site Recruiting
Petach Tikva, Israel
1200.131.97254 Boehringer Ingelheim Investigational Site Recruiting
Tel Hashomer, Israel
Italy
1200.131.03954 Boehringer Ingelheim Investigational Site Recruiting
Brescia, Italy
1200.131.03957 Boehringer Ingelheim Investigational Site Recruiting
Confreria (cn), Italy
1200.131.03951 Boehringer Ingelheim Investigational Site Recruiting
Milano, Italy
1200.131.03960 Boehringer Ingelheim Investigational Site Recruiting
Milano, Italy
1200.131.03955 Boehringer Ingelheim Investigational Site Recruiting
Milano, Italy
1200.131.03953 Boehringer Ingelheim Investigational Site Recruiting
Napoli, Italy
1200.131.03961 Boehringer Ingelheim Investigational Site Recruiting
Reggio Emilia, Italy
1200.131.03959 Boehringer Ingelheim Investigational Site Recruiting
Roma, Italy
1200.131.03952 Boehringer Ingelheim Investigational Site Recruiting
Savona, Italy
1200.131.03958 Boehringer Ingelheim Investigational Site Recruiting
Viterbo, Italy
Japan
1200.131.08161 Boehringer Ingelheim Investigational Site Recruiting
Akashi-city, Hyogo, Japan
1200.131.08159 Boehringer Ingelheim Investigational Site Recruiting
Isehara Kanagawa, Japan
1200.131.08153 Boehringer Ingelheim Investigational Site Recruiting
Kashiwa City, Chiba, Japan
1200.131.08157 Boehringer Ingelheim Investigational Site Recruiting
Kobe-city,Hyogo, Japan
1200.131.08163 Boehringer Ingelheim Investigational Site Recruiting
Koto-ku, Tokyo, Japan
1200.131.08158 Boehringer Ingelheim Investigational Site Recruiting
Matsuyama-city, Ehime, Japan
1200.131.08154 Boehringer Ingelheim Investigational Site Recruiting
Meguro-ku, Tokyo, Japan
1200.131.08156 Boehringer Ingelheim Investigational Site Recruiting
Nagoya, Aichi, Japan
1200.131.08164 Boehringer Ingelheim Investigational Site Recruiting
Natori, Miyagi, Japan
1200.131.08160 Boehringer Ingelheim Investigational Site Recruiting
Osaka-shi,Osaka-fu, Japan
1200.131.08151 Boehringer Ingelheim Investigational Site Recruiting
Sapporo City, Hokkaido, Japan
1200.131.08152 Boehringer Ingelheim Investigational Site Recruiting
shimotsuke-shi,Tochigi, Japan
1200.131.08155 Boehringer Ingelheim Investigational Site Recruiting
Sunto-gun, Shizuoka, Japan
Mexico
1200.131.05253 Boehringer Ingelheim Investigational Site Recruiting
Aguascalientes, Mexico
1200.131.05252 Boehringer Ingelheim Investigational Site Recruiting
Mexico, Mexico
Netherlands
1200.131.03152 Boehringer Ingelheim Investigational Site Recruiting
Amsterdam, Netherlands
1200.131.03153 Boehringer Ingelheim Investigational Site Recruiting
Leiden, Netherlands
1200.131.03151 Boehringer Ingelheim Investigational Site Recruiting
Rotterdam, Netherlands
Poland
1200.131.04852 Boehringer Ingelheim Investigational Site Not yet recruiting
Poznan, Poland
1200.131.04851 Boehringer Ingelheim Investigational Site Not yet recruiting
Warszawa, Poland
Portugal
1200.131.35155 Boehringer Ingelheim Investigational Site Recruiting
Almada, Portugal
1200.131.35154 Boehringer Ingelheim Investigational Site Recruiting
Coimbra, Portugal
1200.131.35153 Boehringer Ingelheim Investigational Site Recruiting
Lisboa, Portugal
1200.131.35151 Boehringer Ingelheim Investigational Site Recruiting
Porto, Portugal
1200.131.35152 Boehringer Ingelheim Investigational Site Recruiting
Évora, Portugal
Russian Federation
1200.131.00756 Boehringer Ingelheim Investigational Site Recruiting
Kurski, Russian Federation
1200.131.00751 Boehringer Ingelheim Investigational Site Recruiting
Moscow, Russian Federation
1200.131.00759 Boehringer Ingelheim Investigational Site Recruiting
Moscow, Russian Federation
1200.131.00753 Boehringer Ingelheim Investigational Site Recruiting
Omsk, Russian Federation
1200.131.00761 Boehringer Ingelheim Investigational Site Recruiting
Pyatigorsk, Russian Federation
1200.131.00760 Boehringer Ingelheim Investigational Site Recruiting
Pyatigorsk, Russian Federation
1200.131.00763 Boehringer Ingelheim Investigational Site Recruiting
St. Petersburg, Russian Federation
1200.131.00755 Boehringer Ingelheim Investigational Site Recruiting
Ufa, Russian Federation
1200.131.00762 Boehringer Ingelheim Investigational Site Recruiting
Ufa, Russian Federation
Spain
1200.131.03451 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1200.131.03453 Boehringer Ingelheim Investigational Site Completed
Barcelona, Spain
1200.131.03454 Boehringer Ingelheim Investigational Site Recruiting
Barcelona, Spain
1200.131.03463 Boehringer Ingelheim Investigational Site Recruiting
Girona, Spain
1200.131.03452 Boehringer Ingelheim Investigational Site Recruiting
Hospitalet de Llobregat, Spain
1200.131.03459 Boehringer Ingelheim Investigational Site Recruiting
Lugo, Spain
1200.131.03457 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1200.131.03464 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1200.131.03465 Boehringer Ingelheim Investigational Site Recruiting
Madrid, Spain
1200.131.03456 Boehringer Ingelheim Investigational Site Recruiting
Málaga, Spain
1200.131.03462 Boehringer Ingelheim Investigational Site Recruiting
Málaga, Spain
1200.131.03455 Boehringer Ingelheim Investigational Site Recruiting
Pamplona, Spain
1200.131.03460 Boehringer Ingelheim Investigational Site Recruiting
Pozuelo de Alarcón, Madrid, Spain
1200.131.03466 Boehringer Ingelheim Investigational Site Recruiting
Sevilla, Spain
1200.131.03458 Boehringer Ingelheim Investigational Site Recruiting
Zaragoza, Spain
1200.131.03461 Boehringer Ingelheim Investigational Site Recruiting
Ávila, Spain
Sweden
1200.131.04652 Boehringer Ingelheim Investigational Site Recruiting
Göteborg, Sweden
1200.131.04651 Boehringer Ingelheim Investigational Site Recruiting
Stockholm, Sweden
Switzerland
1200.131.04151 Boehringer Ingelheim Investigational Site Recruiting
Basel, Switzerland
1200.131.04152 Boehringer Ingelheim Investigational Site Recruiting
Bern, Switzerland
Ukraine
1200.131.03852 Boehringer Ingelheim Investigational Site Not yet recruiting
Donetsk, Ukraine
1200.131.03854 Boehringer Ingelheim Investigational Site Not yet recruiting
Kharkiv, Ukraine
1200.131.03851 Boehringer Ingelheim Investigational Site Not yet recruiting
Kiev, Ukraine
United Kingdom
1200.131.04456 Boehringer Ingelheim Investigational Site Recruiting
Denbighshire, United Kingdom
1200.131.04455 Boehringer Ingelheim Investigational Site Recruiting
Edinburgh, United Kingdom
1200.131.04459 Boehringer Ingelheim Investigational Site Recruiting
Exeter, United Kingdom
1200.131.04460 Boehringer Ingelheim Investigational Site Recruiting
Glasgow, United Kingdom
1200.131.04453 Boehringer Ingelheim Investigational Site Recruiting
Leicester, United Kingdom
1200.131.04451 Boehringer Ingelheim Investigational Site Recruiting
London, United Kingdom
1200.131.04452 Boehringer Ingelheim Investigational Site Recruiting
Manchester, United Kingdom
1200.131.04454 Boehringer Ingelheim Investigational Site Recruiting
Sheffield, United Kingdom
1200.131.04458 Boehringer Ingelheim Investigational Site Recruiting
Sutton, United Kingdom
1200.131.04457 Boehringer Ingelheim Investigational Site Recruiting
Whitchurch, Cardiff, United Kingdom
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01345669     History of Changes
Other Study ID Numbers: 1200.131, 2011-000392-14
Study First Received: April 28, 2011
Last Updated: August 20, 2014
Health Authority: Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Austria: Federal Office for Safety in Health Care
Austria: Medicines and Medical Devices Agency
Belgium: Federal Agency for Medicinal and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Denmark: The Danish Health and Medicines Authority
Egypt: Ministry of Health and Population
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
Israel: Ministry of Health
Italy: Ethics Committee
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Central Committee Research Involving Human Subjects
Poland: Registration Medicinal Product Medical Device Biocidal Product
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Neoplasms
Carcinoma, Squamous Cell
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site

ClinicalTrials.gov processed this record on August 20, 2014