Head and Neck CancerPhase 2NCT00542308
Zalutumumab in Non-curable Patients With SCCHN
A Phase 2 study testing Zalutumumab in people with Head and Neck Cancer and Squamous Cell Cancer, run by Genmab at 48 sites in 11 countries.
Trial summary
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Squamous Cell Cancer
- 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
- 90 participants
- Where
- 48 sitesin 11 countries
- Study dates
- Jan 2008to Aug 2011
- Phase
- Phase 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
- Males and females age ≥ 18 years
- Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- Failure to at least one course of standard platinum-based chemotherapy
Who cannot join
- Three or more prior chemotherapy regimens
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
Trial locations and contacts
48 sites in 11 countries.
48 sites in 11 countries
United States9 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0012
Mountain States Tumor Institute
Boise, Idaho, 83712
University Of Chicago Medical Center
Chicago, Illinois, 60637
Baylor University Medical Center
Dallas, Texas, 75246
Henry Ford Health Systems
Detroit, Michigan, 48202
Ft. Wayne Medical Oncology/Hematology, Inc
Fort Wayne, Indiana, 46815
Loma Linda University Cancer Institute
Loma Linda, California, 92354
Oregon Health and Science University
Portland, Oregon, 97239
Moffitt Cancer Center
Tampa, Florida, 33612
Germany6 sites
Universitätsklinikum Essen
Essen, 45122
Klinikum der Johann Wolfgang Goethe Universität
Frankfurt am Main, 60590
Uniklinik Freiburg
Freiburg im Breisgau, 79106
Universitätsklinikum Heidelberg
Heidelberg, 69120
Medizinische Universitätsklinik Lübeck
Lübeck, 23538
Südharz-Krankenhaus Nordhausen gGmbH
Nordhausen, 99734
Israel6 sites
Soroka Medical Center
Beersheba, 84101
Rambam Medial Center
Haifa, 31096
Shaare-Zedek Medical Center
Jerusalem, 91031
Rabin Medical Center
Petah Tikva, 49100
Sheba Medical Center
Ramat Gan, 52621
Sourasky Medical Center
Tel Aviv, 64239
Peru5 sites
Hospital Goyeneche
Arequipa
Hospital Nacional Carlos Alberto Seguin Escobedo
Arequipa
Hospital Nacional Almanzor Aguinaga Asenjo
Lambayeque
Hospital Central FAP
Lima
Hospital Nacional Guillermo Almenara Irigoyen
Lima
Colombia4 sites
Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A
Bogotá
Hospital Pablo Tobon Uribe
Medellín
Oncomedica S.A.
Montería
Oncólogos del Occidente S.A.
Pereira
Czechia4 sites
Facultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
Nemocnice Jihlava
Jihlava, 586 33
Veseobecna Fakultni Nemocnice
Prague, 128 08
Facultni Nemocnice Na Bulovce
Prague, 180 81
Austria3 sites
Medizinische Universität Graz
Graz, 8036
Universitätsklinik für Innere Medizin III
Salzburg, 5020
AKH Wien
Vienna, 1090
Chile3 sites
Instituto Clinico Oncologico del Sur ICOS
Temuco
Hospital Carlos Van Buren de Valparaiso
Valparaíso
Instituto Oncologico
Viña del Mar
Italy3 sites
Istituto Nazionale Tumori
Milan, 20133
Istituto Europea di Oncologia
Milan, 20141
Azienda Ospedaliera Valtellina e Valchiavenna
Sondrio, 23100
Portugal3 sites
IPO Coimbra
Coimbra, 3000-075
IPO Lisboa
Lisbon, 1099-023
IPO Porto
Porto, 4200-072
Slovakia2 sites
Narodny onkologicky ustav
Bratislava, 83310
FN Trnava
Trnava, 917 75
About this study
Official title: An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Being tested
- Zalutumumab
- Medical subject headings
- Head and Neck Neoplasms, Neoplasms, Squamous Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZalutumumabDrug
Individual dose titration weekly i.v. doses
| Study group | Role | What they receive |
|---|---|---|
| Zalutumumab 4-16 mg/kg | Experimental | Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. Receives: Drug: Zalutumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
OS was defined as time from start of treatment until date of death of any cause.
Measured: From randomization until death, assessed up to 21 months
Secondary outcomes (3)
Objective Tumour Response
Objective Tumour response according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0). Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the longest diameter of target lesions; Overall Response (OR), CR+PR. Stable disease is Responses not fulfilling CR, PR or progressive disease (PD). PD is At least a 20% increase in the sum of the 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: During treatment and two weeks after end of treatment, assessed up to 21 months.
Duration of Response
DOR is defined among responders, as the time from the initial documentation of response to the date of disease progression or death, whichever occurs earlier.
Measured: During treatment and two weeks after end of treatment, assessed up to 21 months
Progression Free Survival (PFS)
PFS is defined as the time from start of treatment until disease progression or death.
Measured: During treatment and two weeks after end of treatment, assessed up to 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2007 (estimated)
- Study startJan 2008
- Primary completionAug 2011
- Study completionAug 2011
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 CancerStudies 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 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genmab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steen Lisby, MD, Study director, Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00542308
- Sponsor's protocol ID
- GEN205
- Status last verified
- Aug 2023
- First submitted
- 10 Oct 2007
- Last updated
- 3 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9.
PubMed 24714973
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Single Arm Trial Investigating Zalutumumab, a Human Monoclonal Anti-EGF Receptor Antibody, in Combination With Best Supportive Care, in Patients With Non-Curable Squamous Cell Carcinoma of the Head and Neck Who Have Failed Standard Platinum-based Chemotherapy.
- ClinicalTrials.gov ID
- NCT00542308
- Acronym / sponsor ID
- GEN205
- Conditions
- Head and Neck Cancer, Squamous Cell Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- GenmabIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 11 Oct 2007 (estimated)
- Results
- Posted 27 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zalutumumab 4-16 mg/kg | Experimental | Drug: ZalutumumabZalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females age ≥ 18 years
- Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
- Failure to at least one course of standard platinum-based chemotherapy
Key exclusion criteria (3 listed)
- Three or more prior chemotherapy regimens
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
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 |
|---|---|---|
| ZalutumumabIndividual dose titration weekly i.v. doses | Drug | Zalutumumab 4-16 mg/kg |
Primary outcome
Overall Survival (OS)
Time frame: From randomization until death, assessed up to 21 months
OS was defined as time from start of treatment until date of death of any cause.
3 secondary outcomes
Objective Tumour Response
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months.
Duration of Response
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
Progression Free Survival (PFS)
Time frame: During treatment and two weeks after end of treatment, assessed up to 21 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24714973Saloura V, Cohen EE, Licitra L, Billan S, Dinis J, Lisby S, Gauler TC. An open-label single-arm, phase II trial of zalutumumab, a human monoclonal anti-EGFR antibody, in patients with platinum-refractory squamous cell carcinoma of the head and neck. Cancer Chemother Pharmacol. 2014 Jun;73(6):1227-39. doi: 10.1007/s00280-014-2459-z. Epub 2014 Apr 9.
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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.
Steen Lisby, MD study director
Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark
48 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zalutumumab in people with Head and Neck Cancer and Squamous Cell Cancer, run by Genmab at 48 sites in 11 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 3 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Germany, Israel, Peru, Colombia and 6 more countries. 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 phase mean?
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 27 Aug 2014). 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?
Overall Survival (OS) (time frame: From randomization until death, assessed up to 21 months). 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 NCT00542308, 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 3 Aug 2023.