Zalutumumab in Head and Neck Cancer

Phase 1

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Drug: Zalutumumab

• Registration Number: NCT00093041
• Lead Sponsor: Genmab

Brief Summary

The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12-01
• Study First Submitted: 2004-09-30
• Study First Submitted QC: 2004-09-30
• Study First Posted: 2004-10-01
• Primary Completion: 2005-01-12
• Study Completion: 2005-01-12
• Results First Submitted: 2011-09-12
• Results First Submitted QC: 2011-11-17
• Results First Posted: 2011-12-22
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-09
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Zalutumumab 0.15 mg/kg	Zalutumumab	-
Zalutumumab 0.5 mg/kg	Zalutumumab	-
Zalutumumab 1 mg/kg	Zalutumumab	-
Zalutumumab 2 mg/kg	Zalutumumab	-
Zalutumumab 4 mg/kg	Zalutumumab	-
Zalutumumab 8 mg/kg	Zalutumumab	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	From study start (Day 0) until follow-up period (up to Day 77)	Number of participants reporting at least one adverse event.

Secondary Outcome Measures

Name	Time	Method
Overall Response (OR), Classification	8 weeks	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.

Trial Locations

Locations (5)

Rigshospitalet; 🇩🇰 Copenhagen Ø, Denmark

Odense Universitetshospital; 🇩🇰 Odense, Denmark

Århus Kommunehospital; 🇩🇰 Århus C, Denmark

Universitets Sjukhuset i Lund; 🇸🇪 Lund, Sweden

Uppsala Akademiska Sjukhus; 🇸🇪 Uppsala, Sweden