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OpenTrials
Completed

NCT Number: NCT00542308

Zalutumumab in Non-curable Patients With SCCHN

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

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medizinische Universität Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Zalutumumab

Drug

Individual dose titration weekly i.v. doses

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Genmab

Industry

Registry information

Official study title

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.

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 11, 2007
Registry last updated
Aug 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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