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

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ClinicalTrials.gov Identifier: NCT01046266
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Head and Neck Cancer Drug: RO5083945 Drug: cetuximab Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Cetuximab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A Drug: RO5083945
700mg iv weekly
Active Comparator: B Drug: cetuximab
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses



Primary Outcome Measures :
  1. immune cell infiltration head and neck squamous cell cancer (HNSCC) [ Time Frame: through study completion or early study discontinuation ]

Secondary Outcome Measures :
  1. pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels [ Time Frame: through study completion or early study discontinuation ]
  2. safety and efficacy: AEs, laboratory parameters, tumour assessments [ Time Frame: through study completion or early study discontinuation ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046266


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01046266     History of Changes
Other Study ID Numbers: BP22350
2009-012656-25
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cetuximab
Antineoplastic Agents