Title
Zalutumumab in Head and Neck Cancer
An Open, Single Dose Escalation Study Followed by a Multiple Dose Extension of Anti-EGF Receptor Human Monoclonal Antibody (Zalutumumab) in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
Phase
Phase 1/Phase 2Lead Sponsor
GenmabStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Head and Neck NeoplasmsIntervention/Treatment
zalutumumab ...Study Participants
28The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Weekly infusion
Inclusion Criteria: Histologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, nasal cavity, paranasal sinuses, nasopharynx, oropharynx, hypopharynx or larynx. Primary or recurrent disease for which no curative or established palliative treatments are amenable WHO performance status of 1 or 2. Exclusion Criteria: Received certain other treatments within 4 weeks prior to administration of study drug Previous severe allergic reactions (e.g. angio-edema, severe asthma, or anaphylaxis). Skin disease requiring systemic or local corticosteroid therapy. Known brain metastasis or leptomeningeal disease. Signs or symptoms of acute illness. Bacterial, fungal or viral infection. Certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, myocardial infarction within one year and stomach, lung, heart, hormonal, nerve or blood diseases. Pregnant or breast-feeding women. Women of childbearing age who are unable or unwilling to use an IUD or hormonal birth control during the whole trial. Simultaneous participation in any other trial involving investigational drugs or having participated in a trial within 4 weeks prior to start of trial treatment.
| Event Type | Organ System | Event Term | Zalutumumab 0.15 mg/kg | Zalutumumab 0.5 mg/kg | Zalutumumab 1 mg/kg | Zalutumumab 2 mg/kg | Zalutumumab 4 mg/kg | Zalutumumab 8 mg/kg |
|---|
Number of participants reporting at least one adverse event.
Best Overall Response is defined as the best response from the start of treatment until disease progression (PD) /recurrence and was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST). As per RECIST, PD is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started, OR the appearance of one or more new lesions.
