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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 March 2012 |
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Main ID: |
EUCTR2006-005032-25-GR |
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Date of registration:
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27/10/2006 |
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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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A multi-centre phase II controlled study of Vx-001 in Non Small Cell Lung Cancer (NSCLC)
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Scientific title:
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A multi-centre phase II controlled study of Vx-001 in Non Small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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08/05/2007 |
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Target sample size:
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225 |
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Recruitment status: |
Authorised-recruitment may be ongoing or finished |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-005032-25 |
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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: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Best Supportive Care
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Phase:
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Countries of recruitment
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Greece
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
•Patients have given written informed consent before any study related activities are carried out
•Histologically documented unresectable stage III and IV NSCLC. All histological subtypes are acceptable. Cancer stage must be confirmed and documented by computer tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET) scan or whole body radionuclear body scan.
•Documented stable disease or objective response after primary chemotherapy or chemo-radiotherapy (minimum two cycles of platine-based or non-platine-based chemotherapy and a minimum radiation dose of = 50Gy) for unresectable stage III/IV disease.
•Patients must have completed the primary chemotherapy or chemo-radiotherapy at least four weeks and no later than eight weeks before entering study.
•WHO performance status 0-1
•Neutrophils >1500/µl, lymphocytes >1000/µl, platelets >105/µl, Hgb >10g/dl
•Male or female = 18 years of age
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:
•Receipt of immunotherapy (interferons, interleukins, TNF, GM-CSF, G-CSF, M-CSF) within one month before entering study
•A documented autoimmune or immunodeficiency disease.
•Known HBV, HCV or HIV infections
•Past or current history of neoplasm other than lung cancer, except for curatively treated non-melanoma skin cancer and in situ carcinoma of the cervix.
•Hepatic dysfunction (ALT>2.5 times normal upper limit, AST>2.5 times normal upper limits, bilirubin=1.5 times normal upper limit.
•Renal dysfunction (serum creatinine=2mg/dl)
•Congestive heart failure, uncontrolled angina, uncontrolled hypertension, uncontrolled arrhythmia, myocardial infraction in the previous 6 months
•Acute or chronic infectious disease
•Pregnant or breast-feeding women
•Simultaneous participation in another clinical study
•Known alcohol/drug abuse
•Requires concurrent treatment with a non-permitted drug.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Patients with Non Small Cell Lung Cancer (NSCLC)
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Intervention(s)
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Product Name: NA
Product Code: Vx-001
Pharmaceutical Form: Injection*
INN or Proposed INN: (Arg572)-hTERT(572-580) Acetate/(Tyr572)-hTERT(572-580) Acetate
CAS Number: NA
Current Sponsor code: Vx-001
Other descriptive name: NA
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 4 mg/ml-
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Primary Outcome(s)
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Secondary Objective: •To study HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients for
- Time to tumor progression (TTP)
- Overall survival (OS)
•Correlate percentage of progression at six months with level of TERT expression by tumors in vaccinated patients
•Evaluate immune response
•Evaluate safety profile
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Main Objective:
To study the percentage of progression at six months of HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients
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Primary end point(s): •To study the percentage of progression at six months of HLA-A*0201 positive vaccinated and HLA-A*0201 negative non vaccinated patients
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Secondary ID(s)
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Vx-001/202
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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