Zalutumumab in Non-curable Patients With SCCHN

August 2, 2023 updated by: Genmab

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Salzburg, Austria, 5020
        • Universitätsklinik für Innere Medizin III
      • Wien, Austria, 1090
        • AKH Wien
  • Chile
      • Temuco, Chile
        • Instituto Clinico Oncologico del Sur ICOS
      • Valparaiso, Chile
        • Hospital Carlos Van Buren de Valparaiso
      • Viña del Mar, Chile
        • Instituto Oncologico
  • Colombia
      • Bogota, Colombia
        • Centro de Investigaciones Oncologicas Clinica CIO San Diego S.A
      • Medellin, Colombia
        • Hospital Pablo Tobon Uribe
      • Montería, Colombia
        • Oncomedica S.A.
      • Pereira, Colombia
        • Oncólogos del Occidente S.A.
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Facultni Nemocnice Hradec Kralove
      • Jihlava, Czechia, 586 33
        • Nemocnice Jihlava
      • Prague, Czechia, 128 08
        • Veseobecna Fakultni Nemocnice
      • Prague, Czechia, 180 81
        • Facultni Nemocnice Na Bulovce
  • Germany
      • Essen, Germany, 45122
        • Universitätsklinikum Essen
      • Frankfurt am Main, Germany, 60590
        • Klinikum der Johann Wolfgang Goethe Universitat
      • Freiburg, Germany, 79106
        • Uniklinik Freiburg
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Lübeck, Germany, 23538
        • Medizinische Universitätsklinik Lübeck
      • Nordhausen, Germany, 99734
        • Südharz-Krankenhaus Nordhausen gGmbH
  • Israel
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center
      • Haifa, Israel, 31096
        • Rambam Medial Center
      • Jerusalem, Israel, 91031
        • Shaare-Zedek Medical Center
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center
      • Ramat-Gan, Israel, 52621
        • Sheba Medical Center
      • Tel-Aviv, Israel, 64239
        • Sourasky Medical Center
  • Italy
      • Milan, Italy, 20133
        • Istituto Nazionale Tumori
      • Milan, Italy, 20141
        • Istituto Europea di Oncologia
      • Sondrio, Italy, 23100
        • Azienda Ospedaliera Valtellina e Valchiavenna
  • Peru
      • Arequipa, Peru
        • Hospital Goyeneche
      • Arequipa, Peru
        • Hospital Nacional Carlos Alberto Seguin Escobedo
      • Lambayeque, Peru
        • Hospital Nacional Almanzor Aguinaga Asenjo
      • Lima, Peru
        • Hospital Central FAP
      • Lima, Peru
        • Hospital Nacional Guillermo Almenara Irigoyen
  • Portugal
      • Coimbra, Portugal, 3000-075
        • IPO Coimbra
      • Lisboa, Portugal, 1099-023
        • IPO Lisboa
      • Porto, Portugal, 4200-072
        • IPO Porto
  • Slovakia
      • Bratislava, Slovakia, 83310
        • Narodny Onkologicky Ustav
      • Trnava, Slovakia, 917 75
        • FN Trnava
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-0012
        • University of Alabama at Birmingham
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University Cancer Institute
    • Florida
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Ft. Wayne Medical Oncology/Hematology, Inc
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health Systems
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zalutumumab 4-16 mg/kg
Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
Drug: Zalutumumab
Individual dose titration weekly i.v. doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From randomization until death, assessed up to 21 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Tumour Response
Time Frame: 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.
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
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.
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
PFS is defined as the time from start of treatment until disease progression or death.
During treatment and two weeks after end of treatment, assessed up to 21 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genmab

Investigators

  • Study Director: Steen Lisby, MD, Genmab A/S, Bredgade 34, DK-1260 Copenhagen K, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria

October 10, 2007

First Posted (Estimated)

October 11, 2007

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEN205

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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