LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy
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:
NCT01345682
First received: April 28, 2011
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate
| Condition | Intervention | Phase |
|---|---|---|
|
Head and Neck Neoplasms Carcinoma, Squamous Cell |
Drug: Afatinib Drug: Methotrexate |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Randomised, Open-label, Phase III Study to Evaluate the Efficacy of Oral Afatinib (BIBW 2992) Versus Intravenous Methotrexate in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma Who Have Progressed After Platinum-based Therapy |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- The primary efficacy endpoint of the trial is progression free survival (PFS) [ Time Frame: Approximately 9 months ] [ 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 9 months ] [ Designated as safety issue: Yes ]
- Overall survival (OS) is the key secondary endpoint [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
- Objective response based on RECIST [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
- Health related quality of life (HRQOL) [ Time Frame: Approximately 9 months ] [ Designated as safety issue: No ]
- Incidence and intensity of adverse events [ Time Frame: Approximately 9 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 474 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | April 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Afatinib (BIBW 2992)
Once daily
|
Drug: Afatinib
Once daily
|
|
Active Comparator: Methotrexate
Weekly
|
Drug: Methotrexate
Weekly
|
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 R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
- Documented progressive disease based on investigator assessment according to Response Evaluation Criteria in Solid Tumours (RECIST) following receipt of at least two cycles of cisplatin or carboplatin administered for R/M disease
- Measurable disease according to RECIST
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion criteria:
- Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
- Any other than one previous platinum based systemic regimen given for R/M disease
- Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
- Pregnancy or breast feeding
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345682
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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, Arkansas | |
| 1200.43.00101 Boehringer Ingelheim Investigational Site | Recruiting |
| Little Rock, Arkansas, United States | |
| United States, Florida | |
| 1200.43.00114 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Pembroke Pines, Florida, United States | |
| United States, Illinois | |
| 1200.43.00113 Boehringer Ingelheim Investigational Site | Recruiting |
| Harvey, Illinois, United States | |
| 1200.43.00106 Boehringer Ingelheim Investigational Site | Recruiting |
| Peoria, Illinois, United States | |
| United States, Massachusetts | |
| 1200.43.00110 Boehringer Ingelheim Investigational Site | Recruiting |
| Boston, Massachusetts, United States | |
| United States, Nebraska | |
| 1200.43.00107 Boehringer Ingelheim Investigational Site | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New York | |
| 1200.43.00105 Boehringer Ingelheim Investigational Site | Recruiting |
| Stony Brook, New York, United States | |
| United States, Pennsylvania | |
| 1200.43.00102 Boehringer Ingelheim Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| 1200.43.00103 Boehringer Ingelheim Investigational Site | Recruiting |
| Philadelphia, Pennsylvania, United States | |
| United States, Texas | |
| 1200.43.00112 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Houston, Texas, United States | |
| 1200.43.00109 Boehringer Ingelheim Investigational Site | Recruiting |
| San Antonio, Texas, United States | |
| Argentina | |
| 1200.43.05404 Boehringer Ingelheim Investigational Site | Suspended |
| Almagro, Argentina | |
| 1200.43.05401 Boehringer Ingelheim Investigational Site | Recruiting |
| Ciudad Autonoma de Buenos Aires, Argentina | |
| 1200.43.05402 Boehringer Ingelheim Investigational Site | Recruiting |
| Santa Fe, Argentina | |
| 1200.43.05403 Boehringer Ingelheim Investigational Site | Recruiting |
| Villa Dominico, Argentina | |
| Austria | |
| 1200.43.04302 Boehringer Ingelheim Investigational Site | Recruiting |
| Graz, Austria | |
| 1200.43.04303 Boehringer Ingelheim Investigational Site | Recruiting |
| Leoben, Austria | |
| 1200.43.04305 Boehringer Ingelheim Investigational Site | Recruiting |
| Salzburg, Austria | |
| 1200.43.04301 Boehringer Ingelheim Investigational Site | Recruiting |
| Wien, Austria | |
| 1200.43.04306 Boehringer Ingelheim Investigational Site | Recruiting |
| Wien, Austria | |
| Belgium | |
| 1200.43.03202 Boehringer Ingelheim Investigational Site | Recruiting |
| Bruxelles, Belgium | |
| 1200.43.03203 Boehringer Ingelheim Investigational Site | Recruiting |
| Edegem, Belgium | |
| 1200.43.03204 Boehringer Ingelheim Investigational Site | Recruiting |
| Gent, Belgium | |
| 1200.43.03201 Boehringer Ingelheim Investigational Site | Recruiting |
| Leuven, Belgium | |
| Brazil | |
| 1200.43.05504 Boehringer Ingelheim Investigational Site | Recruiting |
| Barretos, Brazil | |
| 1200.43.05505 Boehringer Ingelheim Investigational Site | Recruiting |
| Jau, Brazil | |
| 1200.43.05507 Boehringer Ingelheim Investigational Site | Recruiting |
| Passo Fundo, Brazil | |
| 1200.43.05503 Boehringer Ingelheim Investigational Site | Recruiting |
| Porto Alegre, Brazil | |
| 1200.43.05502 Boehringer Ingelheim Investigational Site | Recruiting |
| Rio de Janeiro, Brazil | |
| 1200.43.05501 Boehringer Ingelheim Investigational Site | Recruiting |
| Sao Paulo, Brazil | |
| 1200.43.05506 Boehringer Ingelheim Investigational Site | Recruiting |
| Sao Paulo, Brazil | |
| Czech Republic | |
| 1200.43.04202 Boehringer Ingelheim Investigational Site | Recruiting |
| Olomouc, Czech Republic | |
| 1200.43.04203 Boehringer Ingelheim Investigational Site | Recruiting |
| Prague 2, Czech Republic | |
| 1200.43.04201 Boehringer Ingelheim Investigational Site | Recruiting |
| Prague 8, Czech Republic | |
| Denmark | |
| 1200.43.04501 Boehringer Ingelheim Investigational Site | Recruiting |
| København Ø, Denmark | |
| France | |
| 1200.43.03304 Boehringer Ingelheim Investigational Site | Recruiting |
| Avignon Cedex 9, France | |
| 1200.43.03306 Boehringer Ingelheim Investigational Site | Recruiting |
| Clermont-Ferrand cedex 1, France | |
| 1200.43.03312 Boehringer Ingelheim Investigational Site | Recruiting |
| Dijon Cedex, France | |
| 1200.43.03303 Boehringer Ingelheim Investigational Site | Recruiting |
| Lille Cedex, France | |
| 1200.43.03301 Boehringer Ingelheim Investigational Site | Recruiting |
| Lyon Cedex, France | |
| 1200.43.03302 Boehringer Ingelheim Investigational Site | Recruiting |
| Montpellier cedex 5, France | |
| 1200.43.03307 Boehringer Ingelheim Investigational Site | Recruiting |
| Nice cedex 2, France | |
| 1200.43.03314 Boehringer Ingelheim Investigational Site | Recruiting |
| Paris Cedex 05, France | |
| 1200.43.03305 Boehringer Ingelheim Investigational Site | Recruiting |
| Poitiers, France | |
| 1200.43.03316 Boehringer Ingelheim Investigational Site | Recruiting |
| Rouen Cedex 1, France | |
| 1200.43.03309 Boehringer Ingelheim Investigational Site | Recruiting |
| Saint Herblain Cedex, France | |
| 1200.43.03310 Boehringer Ingelheim Investigational Site | Recruiting |
| Vandoeuvre les Nancy cedex, France | |
| 1200.43.03317 Boehringer Ingelheim Investigational Site | Recruiting |
| Villejuif Cedex, France | |
| Germany | |
| 1200.43.04903 Boehringer Ingelheim Investigational Site | Recruiting |
| Aachen, Germany | |
| 1200.43.04902 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 1200.43.04909 Boehringer Ingelheim Investigational Site | Recruiting |
| Dresden, Germany | |
| 1200.43.04901 Boehringer Ingelheim Investigational Site | Recruiting |
| Essen, Germany | |
| 1200.43.04905 Boehringer Ingelheim Investigational Site | Recruiting |
| Hamburg, Germany | |
| 1200.43.04906 Boehringer Ingelheim Investigational Site | Recruiting |
| Hannover, Germany | |
| 1200.43.04908 Boehringer Ingelheim Investigational Site | Recruiting |
| Jena, Germany | |
| 1200.43.04904 Boehringer Ingelheim Investigational Site | Recruiting |
| Leipzig, Germany | |
| 1200.43.04907 Boehringer Ingelheim Investigational Site | Recruiting |
| Mannheim, Germany | |
| Greece | |
| 1200.43.03001 Boehringer Ingelheim Investigational Site | Recruiting |
| Athens, Greece | |
| 1200.43.03004 Boehringer Ingelheim Investigational Site | Recruiting |
| Haidari, Greece | |
| 1200.43.03005 Boehringer Ingelheim Investigational Site | Recruiting |
| Heraklion, Greece | |
| 1200.43.03007 Boehringer Ingelheim Investigational Site | Not yet recruiting |
| Marousi, Greece | |
| 1200.43.03006 Boehringer Ingelheim Investigational Site | Recruiting |
| Piraeus, Greece | |
| 1200.43.03002 Boehringer Ingelheim Investigational Site | Recruiting |
| Thessaloniki, Greece | |
| Israel | |
| 1200.43.97201 Boehringer Ingelheim Investigational Site | Recruiting |
| Haifa, Israel | |
| 1200.43.97203 Boehringer Ingelheim Investigational Site | Recruiting |
| Petach Tikva, Israel | |
| 1200.43.97202 Boehringer Ingelheim Investigational Site | Recruiting |
| Tel Aviv, Israel | |
| 1200.43.97204 Boehringer Ingelheim Investigational Site | Recruiting |
| Tel Hashomer, Israel | |
| Italy | |
| 1200.43.03909 Boehringer Ingelheim Investigational Site | Recruiting |
| Aosta, Italy | |
| 1200.43.03908 Boehringer Ingelheim Investigational Site | Recruiting |
| Cagliari, Italy | |
| 1200.43.03901 Boehringer Ingelheim Investigational Site | Recruiting |
| Confreria (cn), Italy | |
| 1200.43.03907 Boehringer Ingelheim Investigational Site | Recruiting |
| Milano, Italy | |
| 1200.43.03903 Boehringer Ingelheim Investigational Site | Recruiting |
| Napoli, Italy | |
| 1200.43.03905 Boehringer Ingelheim Investigational Site | Recruiting |
| Palermo, Italy | |
| 1200.43.03902 Boehringer Ingelheim Investigational Site | Recruiting |
| Savona, Italy | |
| 1200.43.03904 Boehringer Ingelheim Investigational Site | Recruiting |
| Taormina (me), Italy | |
| 1200.43.03906 Boehringer Ingelheim Investigational Site | Recruiting |
| Venezia, Italy | |
| 1200.43.03910 Boehringer Ingelheim Investigational Site | Recruiting |
| Viterbo, Italy | |
| Japan | |
| 1200.43.08111 Boehringer Ingelheim Investigational Site | Recruiting |
| Akashi-city, Hyogo, Japan | |
| 1200.43.08109 Boehringer Ingelheim Investigational Site | Recruiting |
| Isehara Kanagawa, Japan | |
| 1200.43.08103 Boehringer Ingelheim Investigational Site | Recruiting |
| Kashiwa City, Chiba, Japan | |
| 1200.43.08107 Boehringer Ingelheim Investigational Site | Recruiting |
| Kobe-city,Hyogo, Japan | |
| 1200.43.08113 Boehringer Ingelheim Investigational Site | Recruiting |
| Koto-ku, Tokyo, Japan | |
| 1200.43.08108 Boehringer Ingelheim Investigational Site | Recruiting |
| Matsuyama-city, Ehime, Japan | |
| 1200.43.08104 Boehringer Ingelheim Investigational Site | Recruiting |
| Meguro-ku, Tokyo, Japan | |
| 1200.43.08112 Boehringer Ingelheim Investigational Site | Recruiting |
| Minato-ku, Tokyo, Japan | |
| 1200.43.08106 Boehringer Ingelheim Investigational Site | Recruiting |
| Nagoya, Aichi, Japan | |
| 1200.43.08110 Boehringer Ingelheim Investigational Site | Recruiting |
| Osaka-shi,Osaka-fu, Japan | |
| 1200.43.08101 Boehringer Ingelheim Investigational Site | Recruiting |
| Sapporo City, Hokkaido, Japan | |
| 1200.43.08102 Boehringer Ingelheim Investigational Site | Recruiting |
| shimotsuke-shi,Tochigi, Japan | |
| 1200.43.08105 Boehringer Ingelheim Investigational Site | Recruiting |
| Sunto-gun, Shizuoka, Japan | |
| Mexico | |
| 1200.43.05202 Boehringer Ingelheim Investigational Site | Recruiting |
| Mexico, Mexico | |
| Russian Federation | |
| 1200.43.00704 Boehringer Ingelheim Investigational Site | Recruiting |
| Ivanovo, Russian Federation | |
| 1200.43.00706 Boehringer Ingelheim Investigational Site | Recruiting |
| Kurski, Russian Federation | |
| 1200.43.00701 Boehringer Ingelheim Investigational Site | Recruiting |
| Moscow, Russian Federation | |
| 1200.43.00709 Boehringer Ingelheim Investigational Site | Recruiting |
| Moscow, Russian Federation | |
| 1200.43.00703 Boehringer Ingelheim Investigational Site | Recruiting |
| Omsk, Russian Federation | |
| 1200.43.00710 Boehringer Ingelheim Investigational Site | Recruiting |
| Pyatigorsk, Russian Federation | |
| 1200.43.00707 Boehringer Ingelheim Investigational Site | Recruiting |
| St. Petersburg, Russian Federation | |
| 1200.43.00708 Boehringer Ingelheim Investigational Site | Recruiting |
| Tula, Russian Federation | |
| 1200.43.00705 Boehringer Ingelheim Investigational Site | Recruiting |
| Ufa, Russian Federation | |
| South Africa | |
| 1200.43.02703 Boehringer Ingelheim Investigational Site | Recruiting |
| Cape Town, South Africa | |
| 1200.43.02704 Boehringer Ingelheim Investigational Site | Recruiting |
| Kraaifontein, Cape Town, South Africa | |
| 1200.43.02701 Boehringer Ingelheim Investigational Site | Recruiting |
| Parktown, Johannesburg, South Africa | |
| 1200.43.02705 Boehringer Ingelheim Investigational Site | Recruiting |
| Port Elizabeth, South Africa | |
| 1200.43.02702 Boehringer Ingelheim Investigational Site | Recruiting |
| Pretoria, South Africa | |
| Spain | |
| 1200.43.03401 Boehringer Ingelheim Investigational Site | Recruiting |
| Barcelona, Spain | |
| 1200.43.03404 Boehringer Ingelheim Investigational Site | Recruiting |
| Barcelona, Spain | |
| 1200.43.03405 Boehringer Ingelheim Investigational Site | Recruiting |
| Girona, Spain | |
| 1200.43.03406 Boehringer Ingelheim Investigational Site | Recruiting |
| Málaga, Spain | |
| 1200.43.03402 Boehringer Ingelheim Investigational Site | Recruiting |
| Salamanca, Spain | |
| 1200.43.03403 Boehringer Ingelheim Investigational Site | Recruiting |
| Zaragoza, Spain | |
| Sweden | |
| 1200.43.04602 Boehringer Ingelheim Investigational Site | Recruiting |
| Göteborg, Sweden | |
| 1200.43.04601 Boehringer Ingelheim Investigational Site | Recruiting |
| Stockholm, Sweden | |
| Switzerland | |
| 1200.43.04101 Boehringer Ingelheim Investigational Site | Recruiting |
| Basel, Switzerland | |
| 1200.43.04102 Boehringer Ingelheim Investigational Site | Recruiting |
| Bern, Switzerland | |
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: | NCT01345682 History of Changes |
| Other Study ID Numbers: | 1200.43, 2011-000391-34 |
| Study First Received: | April 28, 2011 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Argentina: Admin Nacional de Medicamentos, Alimentos Tecnologia Medica Austria: Medicines and Medical Devices Agency Belgium: Federal Agency for Medicinal and Health Products Brazil: National Health Surveillance Agency Czech Republic: State Institute for Drug Control Denmark: Danish 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 Israel: Ministry of Health Italy: Ethics Committee Japan: Pharmaceuticals and Medical Devices Agency Mexico: Federal Commission for Protection Against Health Risks Russia: Pharmacological Committee, Ministry of Health South Africa: Medicines Control Council Spain: Spanish Agency of Medicines Sweden: Medical Products Agency Switzerland: Swissmedic United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Carcinoma, Squamous Cell Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms by Site Methotrexate Abortifacient Agents, Nonsteroidal Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs |
Pharmacologic Actions Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Antirheumatic Agents Nucleic Acid Synthesis Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013