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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:
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
History of Changes
  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:

U.S. FDA Resources

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:

  1. Histologically or cytologically confirmed R/M HNSCC of the oral cavity, oropharynx, hypopharynx or larynx, not amenable for salvage surgery or radiotherapy
  2. 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
  3. Measurable disease according to RECIST
  4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria:

  1. Progressive disease within three months of completion of curatively intended treatment for locoregionally advanced or metastatic HNSCC
  2. Any other than one previous platinum based systemic regimen given for R/M disease
  3. Prior treatment with epidermal growth factor receptor (EGFR)-targeted small molecules
  4. Pregnancy or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01345682

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

  Show 115 Study Locations
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 23, 2013