An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma
Phase 1
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer
Both
Head and Neck Cancer
Trial Information
An Exploratory, Open Label Multicenter Study to Investigate Pharmacodynamic of RO5083945, a Human Monoclonal Antibody Antagonist of Epidermal Growth Factor Receptor (EGFR), Compared to Cetuximab in Patients With Operable Head and Neck Squamous Cell Carcinoma
Inclusion Criteria:
- adult patients, >/=18 years of age
- squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx
Exclusion Criteria:
- carcinoma of nasal cavity, paranasal sinus and nasopharynx
- recurrent squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or
larynx
- known positivity for HIV, hepatitis B and/or hepatitis C infection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
immune cell infiltration head and neck squamous cell cancer (HNSCC)
Outcome Time Frame:
through study completion or early study discontinuation
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: Ministry of Health
Study ID:
BP22350
NCT ID:
NCT01046266
Start Date:
December 2009
Completion Date:
December 2012
Related Keywords:
- Head and Neck Cancer
- Carcinoma
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms
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