Phase 3
Completed N=286
Zalutumumab in Patients With Non-curable Head and Neck Cancer
Head and Neck Cancer · Squamous Cell Cancer
Source: ClinicalTrials.gov NCT00382031 ↗
Enrolled (actual)
286
Serious AEs
94.4%
Results posted
Oct 2013
Primary outcomePrimary: Overall Survival — 6.7; 5.2 months
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
6.7; 5.2 | — |
| SECONDARY Objective Tumor Response |
2; 0; 10; 1; 79; 25 | — |
| SECONDARY Duration of Response |
5.5; 7.4 | — |
| SECONDARY Progression Free Survival (PFS) |
9.9; 8.4 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00382031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.