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

Roche

Status and phase: Completed; Phase 1

Conditions: Head and Neck Cancer

Treatments: Drug: RO5083945; Drug: cetuximab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01046266

BP22350

2009-012656-25

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: RO5083945

B

Active Comparator group

Treatment:

Drug: cetuximab