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

September 12, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France, 31059
      • Villejuif, France, 94805
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20162
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
  • Spain
      • Barcelona, Spain, 08035
      • Sevilla, Spain, 41013
  • United Kingdom
      • London, United Kingdom, SE1 9RT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
immune cell infiltration head and neck squamous cell cancer (HNSCC)
Time Frame: through study completion or early study discontinuation
through study completion or early study discontinuation

Secondary Outcome Measures

Outcome Measure
Time Frame
pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
Time Frame: through study completion or early study discontinuation
through study completion or early study discontinuation
safety and efficacy: AEs, laboratory parameters, tumour assessments
Time Frame: through study completion or early study discontinuation
through study completion or early study discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 16, 2009

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP22350
  • 2009-012656-25

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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