Head and Neck NeoplasmsPhase 1/2NCT00093041
Zalutumumab in Head and Neck Cancer
A Phase 1/2 study testing Zalutumumab in people with Head and Neck Neoplasms, run by Genmab at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Zalutumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Dec 2003to 12 Jan 2005
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Denmark3 sites
Århus Kommunehospital
Århus C, 8000
Rigshospitalet
Copenhagen Ø, 2100
Odense Universitetshospital
Odense, 5000
Sweden2 sites
Universitets Sjukhuset i Lund
Lund, 221 85
Uppsala Akademiska Sjukhus
Uppsala, 751 85
About this study
Official title: 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)
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Zalutumumab
- Keywords
- Head and neck cancer, squamous cell carcinoma of the head and neck
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZalutumumabDrug
Also called HuMax-EGFr
Weekly infusion
| Study group | Role | What they receive |
|---|---|---|
| Zalutumumab 0.15 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
| Zalutumumab 0.5 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
| Zalutumumab 1 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
| Zalutumumab 2 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
| Zalutumumab 4 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
| Zalutumumab 8 mg/kg | Experimental | Not described Receives: Drug: Zalutumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of participants reporting at least one adverse event.
Measured: From study start (Day 0) until follow-up period (up to Day 77)
Secondary outcomes (1)
Overall Response (OR), Classification
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2004 (estimated)
- Study start1 Dec 2003
- Primary completion12 Jan 2005
- Study completion12 Jan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by GenmabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00093041
- Sponsor's protocol ID
- Hx-EGFr-001
- Status last verified
- Jun 2023
- First submitted
- 30 Sep 2004
- Last updated
- 28 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 17602769
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT00093041
- Acronym / sponsor ID
- Hx-EGFr-001
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and neck cancer, squamous cell carcinoma of the head and neck
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2003 (actual)
- Primary completion
- 12 Jan 2005 (actual)
- Study completion
- 12 Jan 2005 (actual)
- First posted
- 1 Oct 2004 (estimated)
- Results
- Posted 22 Dec 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to determine the safety of zalutumumab as a treatment for head and neck cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZalutumumabAlso: HuMax-EGFrWeekly infusion | Drug | 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 |
Primary outcome
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.
1 secondary outcome
Overall Response (OR), Classification
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 17602769Bastholt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Zalutumumab in people with Head and Neck Neoplasms, run by Genmab at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From study start (Day 0) until follow-up period (up to Day 77)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00093041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.