Phase 2
Completed N=90
Zalutumumab in Non-curable Patients With SCCHN
Head and Neck Cancer · Squamous Cell Cancer
Source: ClinicalTrials.gov NCT00542308 ↗
Enrolled (actual)
90
Serious AEs
92.2%
Results posted
Aug 2014
Primary outcomePrimary: Overall Survival (OS) — 5.3 months
Summary
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
5.3 | — |
| SECONDARY Objective Tumour Response |
1; 4; 30; 33; 20 | — |
| SECONDARY Duration of Response |
NA | — |
| SECONDARY Progression Free Survival (PFS) |
8.6 | — |
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 prior chemotherapy regimens
- 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 (NCT00542308). 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.