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.
Verified May 2013 by Boehringer Ingelheim Pharmaceuticals
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01345669
First received: April 28, 2011
Last updated: May 15, 2013
Last verified: May 2013
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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 Pharmaceuticals:
Primary Outcome Measures:
- Disease Free Survival (DFS) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in safety laboratory parameters (Haemoglobin, Leukocytes, Neutrophils, Lymphocytes, Platelets, Potassium, Creatinine, AST, ALT, Bilirubin, Alkaline phosphatase, Proteinuria) [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
- DFS rate at 2 years [ Time Frame: Approximately 5 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 ]
- Incidence and intensity of adverse events [ Time Frame: Approximately 5 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 669 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | August 2017 |
| 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:
- Histologically or cytologically confirmed loco-regionally advanced head and neck squamous cell carcinoma (HNSCC), stage III to IVb
- Unresected tumour prior to chemo-radiotherapy (CRT)
- Concomitant CRT completed prior to randomisation
- After concomitant platinum-based CRT, no evidence of disease (NED) on clinical and radiographic examinations
- Eastern cooperative oncology group (ECOG) performance status 0 or 1
Exclusion criteria:
- Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules, EGFR-targeted antibodies, and/or any investigational agents for HNSCC
- 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
- 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
- Known pre-existing Interstitial Lung Disease (ILD)
- Pregnancy or breast feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345669
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Contacts
| Contact: Boehringer Ingelheim Call Center | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| 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 | Not yet recruiting |
| Aurora, Colorado, United States | |
| United States, Connecticut | |
| 1200.131.00185 Boehringer Ingelheim Investigational Site | Recruiting |
| New Haven, Connecticut, 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, Ohio | |
| 1200.131.00189 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Cleveland, Ohio, 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 | Recruiting |
| San Antonio, Texas, United States | |
| United States, Washington | |
| 1200.131.00183 Boehringer Ingelheim Investigational Site | Recruiting |
| Wenatchee, Washington, United States | |
| Argentina | |
| 1200.131.05454 Boehringer Ingelheim Investigational Site | Withdrawn |
| Almagro, Argentina | |
| 1200.131.05455 Boehringer Ingelheim Investigational Site | Recruiting |
| Buenos Aires, Argentina | |
| 1200.131.05451 Boehringer Ingelheim Investigational Site | Recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina | |
| 1200.131.05456 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Mendoza, 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 | |
| 1200.131.04352 Boehringer Ingelheim Investigational Site | Recruiting |
| Graz, Austria | |
| 1200.131.04353 Boehringer Ingelheim Investigational Site | Recruiting |
| Leoben, Austria | |
| 1200.131.04355 Boehringer Ingelheim Investigational Site | Recruiting |
| Salzburg, Austria | |
| 1200.131.04351 Boehringer Ingelheim Investigational Site | Recruiting |
| Wien, Austria | |
| 1200.131.04356 Boehringer Ingelheim Investigational Site | Recruiting |
| Wien, Austria | |
| 1200.131.04359 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Wien, Austria | |
| 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 | Not yet 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 | |
| 1200.131.05552 Boehringer Ingelheim Investigational Site | Recruiting |
| Rio de Janeiro, 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 | |
| 1200.131.00151 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 | Recruiting |
| 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 | |
| 1200.131.04252 Boehringer Ingelheim Investigational Site | Recruiting |
| Olomouc, Czech Republic | |
| 1200.131.04251 Boehringer Ingelheim Investigational Site | Recruiting |
| Praha 8, Czech Republic | |
| Finland | |
| 1200.131.35856 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Joensuu, Finland | |
| 1200.131.35855 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Kuopio, Finland | |
| 1200.131.35853 Boehringer Ingelheim Investigational Site | Recruiting |
| Oulu, Finland | |
| 1200.131.35851 Boehringer Ingelheim Investigational Site | Recruiting |
| Turku, Finland | |
| France | |
| 1200.131.03358 Boehringer Ingelheim Investigational Site | Recruiting |
| Besançon Cedex, France | |
| 1200.131.03360 Boehringer Ingelheim Investigational Site | Recruiting |
| Clichy Cedex, France | |
| 1200.131.03353 Boehringer Ingelheim Investigational Site | Recruiting |
| Le Havre, France | |
| 1200.131.03351 Boehringer Ingelheim Investigational Site | Recruiting |
| Lille Cedex, France | |
| 1200.131.03362 Boehringer Ingelheim Investigational Site | Recruiting |
| Marseille Cedex 5, France | |
| 1200.131.03361 Boehringer Ingelheim Investigational Site | Recruiting |
| Montbéliard Cedex, France | |
| 1200.131.03363 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Montpellier Cedex 5, France | |
| 1200.131.03359 Boehringer Ingelheim Investigational Site | Recruiting |
| Nice cedex 2, France | |
| 1200.131.03364 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Paris Cedex 5, France | |
| 1200.131.03355 Boehringer Ingelheim Investigational Site | Recruiting |
| Pierre-Bénite, France | |
| 1200.131.03354 Boehringer Ingelheim Investigational Site | Recruiting |
| Saint Herblain Cedex, France | |
| 1200.131.03356 Boehringer Ingelheim Investigational Site | Recruiting |
| Tours, France | |
| 1200.131.03357 Boehringer Ingelheim Investigational Site | Recruiting |
| Villejuif Cedex, France | |
| Germany | |
| 1200.131.04960 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, 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 | |
| 1200.131.04963 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Ulm, Germany | |
| 1200.131.04962 Boehringer Ingelheim Investigational Site | Recruiting |
| Villingen-Schwenningen, Germany | |
| Greece | |
| 1200.131.03051 Boehringer Ingelheim Investigational Site | Recruiting |
| Athens, Greece | |
| 1200.131.03054 Boehringer Ingelheim Investigational Site | Recruiting |
| Chaidari, Greece | |
| 1200.131.03056 Boehringer Ingelheim Investigational Site | Recruiting |
| Marousi, Greece | |
| 1200.131.03057 Boehringer Ingelheim Investigational Site | Recruiting |
| Marousi, Greece | |
| 1200.131.03055 Boehringer Ingelheim Investigational Site | Recruiting |
| Piraeus, Greece | |
| 1200.131.03052 Boehringer Ingelheim Investigational Site | Recruiting |
| Thessaloniki, Greece | |
| Israel | |
| 1200.131.97251 Boehringer Ingelheim Investigational Site | Recruiting |
| Haifa, Israel | |
| 1200.131.97253 Boehringer Ingelheim Investigational Site | Recruiting |
| Petach Tikva, Israel | |
| 1200.131.97252 Boehringer Ingelheim Investigational Site | Recruiting |
| Tel Aviv, 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 | |
| 1200.131.03955 Boehringer Ingelheim Investigational Site | Recruiting |
| Milano, Italy | |
| 1200.131.03960 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 | Not yet 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 | |
| 1200.131.08158 Boehringer Ingelheim Investigational Site | Recruiting |
| Matsuyama-city, Ehime, Japan | |
| 1200.131.08154 Boehringer Ingelheim Investigational Site | Recruiting |
| Meguro-ku, Tokyo, Japan | |
| 1200.131.08162 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Minato-ku, Tokyo, Japan | |
| 1200.131.08156 Boehringer Ingelheim Investigational Site | Recruiting |
| Nagoya, Aichi, 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 | |
| Russian Federation | |
| 1200.131.00754 Boehringer Ingelheim Investigational Site | Recruiting |
| Ivanovo, Russian Federation | |
| 1200.131.00756 Boehringer Ingelheim Investigational Site | Recruiting |
| Kurski, Russian Federation | |
| 1200.131.00751 Boehringer Ingelheim Investigational Site | Not yet 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 | |
| 1200.131.00760 Boehringer Ingelheim Investigational Site | Recruiting |
| Pyatigorsk, Russian Federation | |
| 1200.131.00761 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Pyatigorsk, Russian Federation | |
| 1200.131.00757 Boehringer Ingelheim Investigational Site | Recruiting |
| St. Petersburg, Russian Federation | |
| 1200.131.00758 Boehringer Ingelheim Investigational Site | Recruiting |
| Tula, Russian Federation | |
| 1200.131.00755 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 | Recruiting |
| 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 | |
| 1200.131.03462 Boehringer Ingelheim Investigational Site | Recruiting |
| Málaga, Spain | |
| 1200.131.03456 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 | |
| 1200.131.04653 Boehringer Ingelheim Investigational Site | Recruiting |
| Lund, 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 | |
| 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 | |
| 1200.131.04453 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 Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01345669 History of Changes |
| Other Study ID Numbers: | 1200.131, 2011-000392-14 |
| Study First Received: | April 28, 2011 |
| Last Updated: | May 15, 2013 |
| 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 Publica de Chile Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency 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 India: Israel: Ministry of Health Italy: Ethics Committee Japan: Pharmaceuticals and Medical Devices Agency Mexico: Federal Commission for Protection Against Health Risks Netherlands: Portugal: National Pharmacy and Medicines Institute Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic 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 May 19, 2013