NCT00093041

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2003

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 12, 2005

Completed
6.9 years until next milestone

Results Posted

Study results publicly available

December 22, 2011

Completed
Last Updated

June 28, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

September 30, 2004

Results QC Date

September 12, 2011

Last Update Submit

June 9, 2023

Conditions

Head and Neck Neoplasms

Keywords

Head and neck cancersquamous cell carcinoma of the head and neck

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Number of participants reporting at least one adverse event.

    From study start (Day 0) until follow-up period (up to Day 77)

Secondary Outcomes (1)

  • Overall Response (OR), Classification

    8 weeks

Study Arms (6)

Zalutumumab 0.15 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Zalutumumab 0.5 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Zalutumumab 1 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Zalutumumab 2 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Zalutumumab 4 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Zalutumumab 8 mg/kg

EXPERIMENTAL
Drug: Zalutumumab

Interventions

ZalutumumabDRUG

Weekly infusion

Also known as: HuMax-EGFr
Zalutumumab 0.15 mg/kgZalutumumab 0.5 mg/kgZalutumumab 1 mg/kgZalutumumab 2 mg/kgZalutumumab 4 mg/kgZalutumumab 8 mg/kg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Århus Kommunehospital

Århus C, 8000, Denmark

Location

Rigshospitalet

Copenhagen Ø, 2100, Denmark

Location

Odense Universitetshospital

Odense, 5000, Denmark

Location

Universitets Sjukhuset i Lund

Lund, 221 85, Sweden

Location

Uppsala Akademiska Sjukhus

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • Bastholt L, Specht L, Jensen K, Brun E, Loft A, Petersen J, Kastberg H, Eriksen JG. Phase I/II clinical and pharmacokinetic study evaluating a fully human monoclonal antibody against EGFr (HuMax-EGFr) in patients with advanced squamous cell carcinoma of the head and neck. Radiother Oncol. 2007 Oct;85(1):24-8. doi: 10.1016/j.radonc.2007.06.007. Epub 2007 Jun 28.

    PMID: 17602769RESULT

MeSH Terms

Conditions

Head and Neck NeoplasmsSquamous Cell Carcinoma of Head and Neck

Interventions

zalutumumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Limitations and Caveats

The study comprised a single-dose escalation part for assessment of safety and a repeat dose extension including 4 weekly infusions. Please see the referred publication by Bastholt at al 2007 for detailed results.

Results Point of Contact

Title
VP Clinical Operations Eva Järlid Westerberg
Organization
Genmab A/S
E.Westerberg@genmab.com
+45 7020 2728

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2004

First Posted

October 1, 2004

Study Start

December 1, 2003

Primary Completion

January 12, 2005

Study Completion

January 12, 2005

Last Updated

June 28, 2023

Results First Posted

December 22, 2011

Record last verified: 2023-06

Locations

DK(3)SE(2)