Zalutumumab in Non-curable Patients With SCCHN

Phase 2

Completed

• Conditions: Head and Neck Cancer; Squamous Cell Cancer
• Interventions: Drug: Zalutumumab

• Registration Number: NCT00542308
• Lead Sponsor: Genmab

Brief Summary

Treatment, In combination with BSC, Open-label, Single arm, Efficacy Study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-11
• Study Start: 2008-01
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2014-08-12
• Results First Submitted QC: 2014-08-12
• Results First Posted: 2014-08-27
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-02
• Last Update Posted: 2023-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Males and females age ≥ 18 years
2. Confirmed diagnosis, initially or at relapse, of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
3. Failure to at least one course of standard platinum-based chemotherapy

Exclusion Criteria

1. Three or more prior chemotherapy regimens
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors
3. Past or current malignancy other than SCCHN, except for certain other cancer diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Zalutumumab 4-16 mg/kg	Zalutumumab	Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.

Primary Outcome Measures

Name	Time	Method
Overall Survival (OS)	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.

Secondary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	During treatment and two weeks after end of treatment, assessed up to 21 months	PFS is defined as the time from start of treatment until disease progression or death.
Objective Tumour Response	During treatment and two weeks after end of treatment, assessed up to 21 months.	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.
Duration of Response	During treatment and two weeks after end of treatment, assessed up to 21 months	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.

Trial Locations

Locations (48)

University Of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Universitätsklinik für Innere Medizin III; 🇦🇹 Salzburg, Austria

Nemocnice Jihlava; 🇨🇿 Jihlava, Czechia

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Mountain States Tumor Institute; 🇺🇸 Boise, Idaho, United States

Instituto Oncologico; 🇨🇱 Viña del Mar, Chile

Hospital Nacional Almanzor Aguinaga Asenjo; 🇵🇪 Lambayeque, Peru

IPO Coimbra; 🇵🇹 Coimbra, Portugal

Rambam Medial Center; 🇮🇱 Haifa, Israel

Facultni Nemocnice Na Bulovce; 🇨🇿 Prague, Czechia

Medizinische Universitätsklinik Lübeck; 🇩🇪 Lübeck, Germany

Instituto Clinico Oncologico del Sur ICOS; 🇨🇱 Temuco, Chile

Oncomedica S.A.; 🇨🇴 Montería, Colombia

Hospital Nacional Guillermo Almenara Irigoyen; 🇵🇪 Lima, Peru

IPO Porto; 🇵🇹 Porto, Portugal

Narodny onkologicky ustav; 🇸🇰 Bratislava, Slovakia

Istituto Nazionale Tumori; 🇮🇹 Milan, Italy

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel

Loma Linda University Cancer Institute; 🇺🇸 Loma Linda, California, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Universitätsklinikum Essen; 🇩🇪 Essen, Germany

Medizinische Universität Graz; 🇦🇹 Graz, Austria

AKH Wien; 🇦🇹 Wien, Austria

Hospital Carlos Van Buren de Valparaiso; 🇨🇱 Valparaiso, Chile

Oncólogos del Occidente S.A.; 🇨🇴 Pereira, Colombia

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Hospital Goyeneche; 🇵🇪 Arequipa, Peru

Istituto Europea di Oncologia; 🇮🇹 Milan, Italy

Veseobecna Fakultni Nemocnice; 🇨🇿 Prague, Czechia

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Shaare-Zedek Medical Center; 🇮🇱 Jerusalem, Israel

Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A; 🇨🇴 Bogota, Colombia

Ft. Wayne Medical Oncology/Hematology, Inc; 🇺🇸 Fort Wayne, Indiana, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

FN Trnava; 🇸🇰 Trnava, Slovakia

Uniklinik Freiburg; 🇩🇪 Freiburg, Germany

Südharz-Krankenhaus Nordhausen gGmbH; 🇩🇪 Nordhausen, Germany

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel

Hospital Central FAP; 🇵🇪 Lima, Peru

IPO Lisboa; 🇵🇹 Lisboa, Portugal

Sourasky Medical Center; 🇮🇱 Tel-Aviv, Israel

Azienda Ospedaliera Valtellina e Valchiavenna; 🇮🇹 Sondrio, Italy

Klinikum der Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt am Main, Germany

Hospital Pablo Tobon Uribe; 🇨🇴 Medellin, Colombia

Henry Ford Health Systems; 🇺🇸 Detroit, Michigan, United States

Facultni Nemocnice Hradec Kralove; 🇨🇿 Hradec Králové, Czechia

Hospital Nacional Carlos Alberto Seguin Escobedo; 🇵🇪 Arequipa, Peru