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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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19 April 2022 |
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Main ID: |
EUCTR2008-000582-39-CZ |
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Date of registration:
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15/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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. - Zalutumumab in non-curable Patients with SCCHN
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Scientific title:
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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. - Zalutumumab in non-curable Patients with SCCHN |
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Date of first enrolment:
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15/09/2008 |
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Target sample size:
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100 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000582-39 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Czech Republic
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Germany
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Italy
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Portugal
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Slovakia
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Contacts
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx, considered incurable with standard therapy
2. Patients must have disease progression according to RECIST.
3. Measurable disease defined as one or more target lesions according to RECIST.
4. WHO PS =2
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Three or more prior chemotherapy regimens other than platinum based chemotherapy.
2. Prior treatment with EGFr antibodies and/or EGFr small molecule inhibitors unless given as part of first line treatment of locally or regionally advanced SCCHN in combination with chemotherapy and/or radiotherapy. Exposure to EGFr targeted therapy must be completed = 6 weeks prior to visit 2
3. Received the following treatments within 4 weeks prior to Visit 2:
- Cytotoxic or cytostatic anti-cancer chemotherapy
- Total tumor resection
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Non-Curable Squamous Cell Carcinoma of the Head and Neck
MedDRA version: 9.1
Level: LLT
Classification code 10060121
Term: Squamous cell carcinoma of head and neck
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Intervention(s)
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Product Name: Zalutumumab
Product Code: HuMax-EGFr
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Zalutumumab
CAS Number: 667901-13-5
Current Sponsor code: HuMax-EGFr
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Primary end point(s): Overall Survival (OS) defined as the time from start of treatment until date of death from any cause.
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Main Objective: To investigate zalutumumab in combination with BSC in terms of overall survival in non-curable patients with recurrent and/or metastatic disease who have failed after at least one course of standard-based chemotherapy.
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Secondary Objective: To investigate zalutumumab in combination with BSC with respect to efficacy and safety and to determine the pharmacokinetic profile of zalutumumab.
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Secondary ID(s)
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2008-000582-39-SK
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GEN205
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 07/07/2008
Contact:
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