A Study of Pharmacodynamics of RO5083945 in Patients With Head and Neck Squamous Cell Carcinoma
- Registration Number
- NCT01046266
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A RO5083945 - B cetuximab -
- Primary Outcome Measures
Name Time Method immune cell infiltration head and neck squamous cell cancer (HNSCC) through study completion or early study discontinuation
- Secondary Outcome Measures
Name Time Method safety and efficacy: AEs, laboratory parameters, tumour assessments through study completion or early study discontinuation pharmacodynamics: T lymphocytes, B lymphocytes, NK cells, plasma cytokine levels through study completion or early study discontinuation