NCT00093041CompletedPhase 1
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)
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Genmab
- Enrollment
- 28
- Locations
- 5
- Primary Endpoint
- Adverse Events
Study Overview
Brief Summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Zalutumumab 0.15 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Zalutumumab 0.5 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Zalutumumab 1 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Zalutumumab 2 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Zalutumumab 4 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Zalutumumab 8 mg/kg
Experimental
Intervention: Zalutumumab (Drug)
Outcomes
Primary Outcomes
Adverse Events
Time Frame: From study start (Day 0) until follow-up period (up to Day 77)
Number of participants reporting at least one adverse event.
Secondary Outcomes
- Overall Response (OR), Classification(8 weeks)
Investigators
Study Sites (5)
Loading locations...
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