Status:
COMPLETED
Zalutumumab in Patients With Non-curable Head and Neck Cancer
Lead Sponsor:
Genmab
Conditions:
Head and Neck Cancer
Squamous Cell Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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
Detailed Description
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC. Patients randomiz...
Eligibility Criteria
Inclusion
- Males and Females age ≥ 18 years
- Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- Failure to at least one course of standard platinum-based chemotherapy
Exclusion
- Three or more chemotherapy regimens other than platinum-based chemotherapy
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
286 Patients enrolled
Trial Details
Trial ID
NCT00382031
Start Date
November 1 2006
End Date
August 1 2011
Last Update
October 15 2013
Active Locations (82)
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1
University Hospital Antwerp
Antwerp, Belgium
2
St-Luc University Hospital
Brussels, Belgium
3
CHNDRF
Charleroi, Belgium
4
"University Hospital
Ghent, Belgium