Overview

Zalutumumab in Patients With Non-curable Head and Neck Cancer

Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Genmab
Treatments:
Antibodies, Monoclonal
Zalutumumab
Criteria
Inclusion Criteria:

1. Males and Females age ≥ 18 years

2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy

3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria:

1. Three or more chemotherapy regimens other than platinum-based chemotherapy

2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors

3. Past or current malignancy other than SCCHN, except for certain other cancer diseases