Zalutumumab in Non-curable Patients With SCCHN

NCT00542308 | Completed Phase 2 Results DMC

• 1 other identifier: GEN205
• Study Type: interventional
• Target: 90
• Locations: 11 countries
• Sites: 48

Brief Summary

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

Conditions

Head and Neck Cancer; Squamous Cell Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  OS was defined as time from start of treatment until date of death of any cause.

  From randomization until death, assessed up to 21 months

Secondary Outcomes (3)

• Objective Tumour Response

  During treatment and two weeks after end of treatment, assessed up to 21 months.

• Duration of Response

  During treatment and two weeks after end of treatment, assessed up to 21 months

• Progression Free Survival (PFS)

  During treatment and two weeks after end of treatment, assessed up to 21 months

Study Arms (1)

Zalutumumab 4-16 mg/kg

EXPERIMENTAL

Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.

Drug: Zalutumumab

Interventions

Zalutumumab DRUG

Individual dose titration weekly i.v. doses

Zalutumumab 4-16 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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 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

Sponsors & Collaborators

• Genmab: lead

Study Sites (48)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0012, United States

Location

Loma Linda University Cancer Institute

Loma Linda, California, 92354, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Mountain States Tumor Institute

Boise, Idaho, 83712, United States

Location

University Of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Ft. Wayne Medical Oncology/Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Henry Ford Health Systems

Detroit, Michigan, 48202, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Location

Medizinische Universität Graz

Graz, 8036, Austria

Location

Universitätsklinik für Innere Medizin III

Salzburg, 5020, Austria

Location

AKH Wien

Vienna, 1090, Austria

Location

Instituto Clinico Oncologico del Sur ICOS

Temuco, Chile

Location

Hospital Carlos Van Buren de Valparaiso

Valparaíso, Chile

Location

Instituto Oncologico

Viña del Mar, Chile

Location

Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A

Bogotá, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Colombia

Location

Oncomedica S.A.

Montería, Colombia

Location

Oncólogos del Occidente S.A.

Pereira, Colombia

Location

Facultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

Location

Nemocnice Jihlava

Jihlava, 586 33, Czechia

Location

Veseobecna Fakultni Nemocnice

Prague, 128 08, Czechia

Location

Facultni Nemocnice Na Bulovce

Prague, 180 81, Czechia

Location

Universitätsklinikum Essen

Essen, 45122, Germany

Location

Klinikum der Johann Wolfgang Goethe Universität

Frankfurt am Main, 60590, Germany

Location

Uniklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinikum Heidelberg

Heidelberg, 69120, Germany

Location

Medizinische Universitätsklinik Lübeck

Lübeck, 23538, Germany

Location

Südharz-Krankenhaus Nordhausen gGmbH

Nordhausen, 99734, Germany

Location

Soroka Medical Center

Beersheba, 84101, Israel

Location

Rambam Medial Center

Haifa, 31096, Israel

Location

Shaare-Zedek Medical Center

Jerusalem, 91031, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Sheba Medical Center

Ramat Gan, 52621, Israel

Location

Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Istituto Nazionale Tumori

Milan, 20133, Italy

Location

Istituto Europea di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliera Valtellina e Valchiavenna

Sondrio, 23100, Italy

Location

Hospital Goyeneche

Arequipa, Peru

Location

Hospital Nacional Carlos Alberto Seguin Escobedo

Arequipa, Peru

Location

Hospital Nacional Almanzor Aguinaga Asenjo

Lambayeque, Peru

Location

Hospital Central FAP

Lima, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen

Lima, Peru

Location

IPO Coimbra

Coimbra, 3000-075, Portugal

Location

IPO Lisboa

Lisbon, 1099-023, Portugal

Location

IPO Porto

Porto, 4200-072, Portugal

Location

Narodny onkologicky ustav

Bratislava, 83310, Slovakia

Location

FN Trnava

Trnava, 917 75, Slovakia

Location

Related Publications (1)

• 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.

  PMID: 24714973 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Neoplasms, Squamous Cell

Interventions

zalutumumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

This was an uncontrolled single-arm open-label trial with no formal statistical tests planned.

Results Point of Contact

• Title: Eva Järlid Westerberg, VP Clinical Operations
• Organization: Genmab A/S

E.Westerberg@genmab.com

+45 7020 2728

Study Officials

• Steen Lisby, MD

  Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 11, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 3, 2023
• Results First Posted: August 27, 2014

Record last verified: 2023-08

Locations

SL (2); IT (3); PT (3); DE (6); CZ (4); PE (5); CL (3); US (9); CO (4); IL (6); AU (3)