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A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 16, 2009
Last updated: September 12, 2016
Last verified: September 2016
This open-label study will assess the pharmacodynamics, safety and efficacy of RO5083945 as compared to cetuximab in patients with head and neck squamous cell carcinoma. Patients will receive at least 2 infusions of either RO5083945 or cetuximab. Anticipated time on study treatment is up to 3 months, and target sample size is <50.

Condition Intervention Phase
Head and Neck Cancer
Drug: RO5083945
Drug: cetuximab
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • immune cell infiltration head and neck squamous cell cancer (HNSCC) [ Time Frame: through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels [ Time Frame: through study completion or early study discontinuation ] [ Designated as safety issue: No ]
  • safety and efficacy: AEs, laboratory parameters, tumour assessments [ Time Frame: through study completion or early study discontinuation ] [ Designated as safety issue: No ]

Enrollment: 62
Study Start Date: November 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: RO5083945
700mg iv weekly
Active Comparator: B Drug: cetuximab
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  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 identifier: NCT01046266

Toulouse, France, 31059
Villejuif, France, 94805
Milano, Lombardia, Italy, 20162
Nijmegen, Netherlands, 6525 GA
Barcelona, Spain, 08035
Sevilla, Spain, 41013
United Kingdom
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01046266     History of Changes
Other Study ID Numbers: BP22350  2009-012656-25 
Study First Received: November 16, 2009
Last Updated: September 12, 2016
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site
Antineoplastic Agents processed this record on October 27, 2016