Zalutumumab in Patients With Non-curable Head and Neck Cancer
An Open-Labeled Randomized Parallel Group Trial of Zalutumumab, a Human Monoclonal Anti-EGFr Antibody, in Combination With Best Supportive Care (BSC) vs BSC, in Pts With Non-Curable SCCHN Who Have Failed Standard Platinum-Based Chemotherapy
1 other identifier
interventional
286
11 countries
80
Brief Summary
The purpose of this study is to investigate if zalutumumab in combination with Best Supportive Care (BSC) is superior to BSC in non-curable patients with head and neck cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 head-and-neck-cancer
Started Nov 2006
80 active sites
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
First Submitted
Initial submission to the registry
September 27, 2006
CompletedFirst Posted
Study publicly available on registry
September 28, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedResults Posted
Study results publicly available
October 15, 2013
CompletedOctober 15, 2013
August 1, 2013
3.1 years
September 27, 2006
May 28, 2013
August 9, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Overall Survival
A patient's overall survival was defined as the time from the date of randomization until the date of death from any cause, assessed up to 41 months. Overall survival was censored if the patient was lost to follow-up or refused to continue in the trial.
From randomization until death
Secondary Outcomes (3)
Objective Tumor Response
From date of randomization until the date of death from any cause, assessed up to 41 months.
Duration of Response
Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months.
Progression Free Survival (PFS)
From randomization until disease progression or death, assessed up to 41 months.
Study Arms (2)
zalutumumab
ACTIVE COMPARATORZalutumumab in combination with Best Supportive Care
Control
OTHERBest Supportive Care
Interventions
Individual dose titration weekly i.v doses
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Three or more chemotherapy regimens other than platinum-based chemotherapy
- Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
- Past or current malignancy other than SCCHN, except for certain other cancer diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genmablead
Study Sites (82)
University Hospital Antwerp
Antwerp, Belgium
St-Luc University Hospital
Brussels, Belgium
CHNDRF
Charleroi, Belgium
"University Hospital
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
Cliniques Saint Pierre
Ottignies, Belgium
BioCancer
Belo Horizonte, Brazil
Hospital Erasto Gaertner
Curitiba, Brazil
Centro Goiano de Oncologia
Goiânia, Brazil
Hospital Araújo Jorge
Goiânia, Brazil
Fundação Amaral Carvalho
Jaú, Brazil
CliniOnco
Porto Alegre, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Brazil
Cepho - Centro de Estudos e pesquisa em Hematologia e Oncologia
Santo André, Brazil
Santo Andre Diag e Tratamentos
Santo André, Brazil
Centro de Oncologia - InRad HCFMUSP
São Paulo, Brazil
Hospital Heliópolis
São Paulo, Brazil
IBCC - Instituto Brasileiro de Combate ao Câncer
São Paulo, Brazil
UNIFESP
São Paulo - SP, Brazil
Tom Baker Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
London Regional Cancer Program
London, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
BC Cancer Agency
Vancouver, British Colombia, Canada
North-Estonian Regional Hospital
Tallinn, Estonia
Hôpital Beaujon- department of medical oncology
Clichy, France
Centre Oscar Lambrette
Lille, France
Centre Antoine Lacassagne
Nice, France
Hôpital Tenon - department of medical oncology
Paris, France
Institut Gustave Roussy
Villejuif, France
Semmelweis University
Budapest, Hungary
Uzsoki Hospital Budapest
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Petz Aladár
Győr, Hungary
Szabolcs-Szatmar-Bereg County Hospital
Nyíregyháza, Hungary
University of Szeged
Szeged, Hungary
Markusovszky County Hospital
Szombathely, Hungary
Szent Borbála County Hospital Oncology Department
Tatabánya, Hungary
Zala County Hospital
Zalaegerszeg-Pózca, Hungary
Klaipeda Hospital
Klaipėda, Lithuania
Vilnius University
Vilnius, Lithuania
Beskidzkie Centrum Onkologii
Bielsko-Biala, Poland
Samodzielny Publiczny Szpital Kiniczny Nr1
Gdansk, Poland
Katedra i Onkologii Collegium
Krakow, Poland
Szpital Specjalistyczny im. Rydygiera
Krakow, Poland
Centrum Onkologii
Lublin, Poland
Zakład Opieki Zdrowotnej MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Centrum Onkologii - Instytut im. M. Curie-Skłodowskiej
Warsaw, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, Poland
Szpital Wojewódzki SP ZOZ
Zielona Góra, Poland
Belgorod Regional Oncology Dispensary
Belgorod, Russia
Regional Oncology Dispensary
Chelyabinsk, Russia
Republican Clinical Oncology Dispensary
Izhevsk, Russia
Kursk Regional Oncology Dispencary
Kursk, Russia
Kursk Regional Oncology Dispensary
Kursk, Russia
City Clinincal Oncology Dispensary #1
Moscow, Russia
Moscow Research Institute of Oncology
Moscow, Russia
NUZ Semashko Central Clinical Hospital No2 OAO
Moscow, Russia
Russian Oncology Research Center n.a. Blokhin
Moscow, Russia
GUZ NO Oncology Dispensary
Nizhiy Novgorod, Russia
Medical Radiological Research Center
Obninsk, Russia
St. Petersburg State Medical University
Saint Petersburg, Russia
Sochi Oncology Center
Sochi, Russia
Stavropol Regional Clinical Oncology Dispensary
Stavropol, Russia
Tula Region Oncology Dispensary
Tula, Russia
GUZ Volgograd Region Clinical Oncology Dispensary No1
Volgograd, Russia
Voronezh Region Clinical Oncology Dispensary
Voronezh, Russia
Institute for Oncology and Radiology
Belgrade, Serbia
Military Medical Academy
Belgrade, Serbia
Institute of Oncology Sremska Kamenica
Kamenica, Serbia
Clinic of Maxillofacial Surgery Nis
Niš, Serbia
Sahlgrenska University Hospital
Gothenburg, Sweden
Lund University Hospital
Lund, Sweden
Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Royal Surrey County
Guildford, Surrey, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, United Kingdom
The Beatson West of Scotland Centre
Glasgow, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Christie Hospital
Manchester, United Kingdom
Newcastle General Hospital
Newcastle, United Kingdom
Weston Park Hospital
Sheffield, United Kingdom
New Cross Hospital
Wolverhampton, United Kingdom
Related Publications (1)
Machiels JP, Subramanian S, Ruzsa A, Repassy G, Lifirenko I, Flygare A, Sorensen P, Nielsen T, Lisby S, Clement PM. Zalutumumab plus best supportive care versus best supportive care alone in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after failure of platinum-based chemotherapy: an open-label, randomised phase 3 trial. Lancet Oncol. 2011 Apr;12(4):333-43. doi: 10.1016/S1470-2045(11)70034-1. Epub 2011 Mar 4.
PMID: 21377930DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Eva Järlid Westerberg, VP Clinical Operations
- Organization
- Genmab A/S
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2006
First Posted
September 28, 2006
Study Start
November 1, 2006
Primary Completion
December 1, 2009
Study Completion
August 1, 2011
Last Updated
October 15, 2013
Results First Posted
October 15, 2013
Record last verified: 2013-08