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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01046266
First received: November 16, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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: 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:

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

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: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01046266

Locations
France
Toulouse, France, 31052
Villejuif, France, 94805
Italy
Milano, 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
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01046266     History of Changes
Other Study ID Numbers: BP22350, 2009-012656-25
Study First Received: November 16, 2009
Last Updated: May 7, 2013
Health Authority: France: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013