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Main
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Note: This record shows only the 20 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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00412776 |
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Date of registration:
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14/12/2006 |
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Primary sponsor: |
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Public title:
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Study of Proxinium Plus Best Supportive Care Versus Best Supportive Care for Patients With Advanced Head and Neck Cancer
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Scientific title:
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A Randomized, Multicentre Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of Proxinium Plus Best Supportive Care Versus Best Supportive Care Alone in Patients With Advanced Squamous Cell Carcinoma of the Head and Neck Who Have Received at Least One Anti-Cancer Treatment Regimen for Advanced Disease |
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Date of first enrolment:
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December 2005 |
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Target sample size:
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165 |
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Recruitment status: |
Terminated |
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URL:
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http://clinicaltrials.gov/show/NCT00412776 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Argentina
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Brazil
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Croatia
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Former Serbia and Montenegro
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France
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Germany
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Hungary
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India
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Israel
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Italy
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Mexico
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Poland
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Romania
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Russian Federation
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Serbia
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Slovakia
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Spain
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Ukraine
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United Kingdom
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Contacts
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Name:
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Wendy Cuthbert |
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Address:
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Telephone:
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Email:
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Affiliation:
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Viventia Biotech Inc. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Disease Characteristics
- The patient must be 18 years of age or older.
- The patient must have squamous cell carcinoma of the head and neck.
- The squamous cell carcinoma must be Ep-CAM positive.
- ECOG performance status of 0, 1, 2 or 3.
- 12 week life expectancy
Prior/Concurrent Therapy
- The patient must have received therapy for their primary disease (eg, surgery and/or
radiotherapy, chemo-radiotherapy or chemotherapy).
- The patient must have been diagnosed with persistent or recurrent disease or a second
primary tumour.
- The patient's disease must be refractory.
- There must be at least 2 weeks between the last dose of chemotherapy or radiotherapy
and receiving study drug or 4 weeks between the last dose of an experimental drug and
receiving study drug.
Patient Characteristics
- The patient must have adequate hepatic function [alanine aminotransferase (ALT) and
aspartate aminotransferase (AST) =2.5 × upper limit of normal (ULN) and bilirubin
level =1.5 × ULN].
- The patient must have adequate renal function (serum creatinine < 1.5 × ULN).
- The patient must have the following hematological values: granulocytes =1500/µL,
platelets =75 000/µL and hemoglobin >8 g/dL.
- The patient must have prothrombin time and partial thromboplastin time within normal
limits.
Other
• Women of childbearing potential and male patients must agree to use a highly effective
contraceptive method.
Exclusion Criteria:
- The patient has clinically significant distant metastases.
- The patient is eligible to have surgical resection or radiotherapy,
chemo-radiotherapy or chemotherapy.
- The patient has a nasopharyngeal tumour.
- The patient has AIDS, hepatitis C or hepatitis B.
- The patient has clinically significant renal or hepatic disease.
- Tumors are prone to bleeding.
- The patient is pregnant or lactating.
- The patient requires 'blood thinning' medications and can not safely discontinue the
medication.
- The patient is currently enrolled in another clinical trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Advanced Squamous Cell Carcinoma of the Head and Neck
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Carcinoma, Squamous Cell
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Head and Neck Cancer
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Head and Neck Neoplasms
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Mouth Neoplasms
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Neoplasms, Squamous Cell
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Intervention(s)
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Drug: Proxinium
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Primary Outcome(s)
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Survival
[Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized]
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Secondary Outcome(s)
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Tumour response, safety and quality of life
[Time Frame: Death or 12 months from the date that the last patient required for efficacy analysis has been randomized]
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Secondary ID(s)
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VB4-845-01-IIIA
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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