Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
This is an open parallel group trial. Patients will be randomized in a 2:1 manner to receive either treatment with zalutumumab in combination with Best Supportive Care (BSC) or BSC.
Patients randomized to treatment with zalutumumab in combination with BSC will receive weekly infusions with zalutumumab starting with a loading dose (8mg/kg) followed by weekly maintenance doses until disease progression, intercurrent illness preventing further administration, unacceptable toxicity or patient decision. After Visit 2 the patient should be evaluated for presence of skin rash prior to each infusion to allow dose titration.
Individual dose titration until the patient develops grade 2 skin rash will be applied. The maximum dose used in study will be 16 mg/kg.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zalutumumab | Active Comparator | Zalutumumab in combination with Best Supportive Care |
|
| Control | Other | Best Supportive Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zalutumumab | Drug | Individual dose titration weekly i.v doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Tumor Response | Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | From date of randomization until the date of death from any cause, assessed up to 41 months. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Antwerp | Antwerp | Belgium | ||||
| St-Luc University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21377930 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Zalutumumab | Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed. |
| FG001 | Control |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Control | Other | Best Supportive Care |
|
|
| Duration of Response | Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented. | Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months. |
| Progression Free Survival (PFS) | PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient. | From randomization until disease progression or death, assessed up to 41 months. |
| 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 ClÃnicas 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 | NyÃregyháza | 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 | KlaipÄ—da | 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 |
Best Supportive Care |
| COMPLETED |
|
| NOT COMPLETED |
|
The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Zalutumumab | Zalutumumab in combination with Best Supportive Care |
| BG001 | Control | Best Supportive Care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population. | Posted | Median | 95% Confidence Interval | months | From randomization until death |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Objective Tumor Response | Objective tumor response assessed according to Response Evaluation Criteria in Solid Tumours (RECIST v 1.0) J Natl Cancer Inst 2000;92:205-16 assessed by CT/MRI. 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 | The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population. | Posted | Number | participants | From date of randomization until the date of death from any cause, assessed up to 41 months. |
|
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response | Duration of response defined as the time from the first date where measurement criteria for complete or partial response (whichever status is recorded first) are met until the first date that death, recurrence or progressive disease is objectively documented. | The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population. | Posted | Median | 95% Confidence Interval | month | Time from complete or partial response until death, recurrence or progressive disease, assessed up to 41 months. |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) | PFS (defined as the time from randomization until disease progression or death). The progression events were defined by well-documented and verifiable imaging data. In case of censoring, the date of censoring had to be the last time point documenting the status of the patient. | The full analysis set (FAS) was based on the intent-to-treat principle and thus comprised all randomized patients. The FAS was used for evaluation of all efficacy endpoints and was the primary analysis population. | Posted | Median | 95% Confidence Interval | weeks | From randomization until disease progression or death, assessed up to 41 months. |
|
|
Adverse events were collected during weekly visits for patients treated with zalutumumab and visits every fourth week for patients randomized to the control group.
The safety analysis population included all 283 patients who had attended Visit 2.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zalutumumab | Zalutumumab in combination with Best Supportive Care | 180 | 189 | 188 | 189 | ||
| EG001 | Control | Best Supportive Care | 87 | 94 | 92 | 94 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Disease progression | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Tumour hemorrhage | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Infections and Infestations | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions | General disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Infections and Infestations | Infections and infestations | MedDRA (6.1) | Systematic Assessment |
| |
| Metabolism and nutrition disorders | Metabolism and nutrition disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Blood and lymphatic system disorders | Blood and lymphatic system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Nervous system disorders | Nervous system disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Neoplasms benign, malignant and unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.1) | Systematic Assessment |
| |
| Musculoskeletal and connective tissue disorders | Musculoskeletal and connective tissue disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Investigations | Investigations | MedDRA (6.1) | Systematic Assessment |
| |
| Vascular disorders | Vascular disorders | MedDRA (6.1) | Systematic Assessment |
| |
| Eye disorders | Eye disorders | MedDRA (6.1) | Systematic Assessment |
|
The site and the PI may be required to withhold the publication for up to 90 days. Subject to a reasoned request from the sponsor, the publication may be further delayed for a period up to 6 months from the date of first submission to the sponsor.
The sponsor has the right to require deletion of any trade secret, proprietary, or confidential information supplied by the sponsor to the site or the PI. The sponsor shall not otherwise have the right to censor publications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eva Järlid Westerberg, VP Clinical Operations | Genmab A/S | +45 7020 2728 | E.Westerberg@genmab.com |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D018307 | Neoplasms, Squamous Cell |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
| ID | Term |
|---|---|
| C546618 | zalutumumab |
Not provided
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Estonia |
|
| Spain |
|
| Lithuania |
|
| Russian Federation |
|
| United Kingdom |
|
| France |
|
| Hungary |
|
| Canada |
|
| Brazil |
|
| Belgium |
|
| Poland |
|
| Sweden |
|
|
|
|