Back to resultsA Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO5083945
cetuximab
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
immune cell infiltration head and neck squamous cell cancer (HNSCC)
Secondary Outcome Measures
pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
safety and efficacy: AEs, laboratory parameters, tumour assessments
Full Information
NCT ID
NCT01046266
First Posted
November 16, 2009
Last Updated
September 12, 2016
Sponsor
Hoffmann-La Roche
1. Study Identification
Unique Protocol Identification Number
NCT01046266
Brief Title
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
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 Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
RO5083945
Intervention Description
700mg iv weekly
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
400mg/m2 iv 1st dose, 250mg/m2 iv subsequent weekly doses
Primary Outcome Measure Information:
Title
immune cell infiltration head and neck squamous cell cancer (HNSCC)
Time Frame
through study completion or early study discontinuation
Secondary Outcome Measure Information:
Title
pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels
Time Frame
through study completion or early study discontinuation
Title
safety and efficacy: AEs, laboratory parameters, tumour assessments
Time Frame
through study completion or early study discontinuation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Villejuif
ZIP/Postal Code
94805
Country
France
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20162
Country
Italy
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28950289
Citation
Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the pharmacodynamics of a glycoengineered antibody (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. 2017 Nov 1;28(11):2827-2835. doi: 10.1093/annonc/mdx489.
Results Reference
derived
Learn more about this trial
A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
We'll reach out to this number within 24 hrs