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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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10 December 2019 |
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Main ID: |
EUCTR2009-017422-39-IT |
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Date of registration:
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03/02/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. - TAVAREC
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Scientific title:
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Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. - TAVAREC |
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Date of first enrolment:
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01/02/2011 |
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Target sample size:
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144 |
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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:2009-017422-39 |
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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: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: standard treatment
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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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Belgium
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Germany
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Italy
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Netherlands
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Histologically proven grade II or grade III astrocytoma, oligodendroglioma or oligoastrocytoma. - Demonstrated absence of 1p/19q co-deletion. - Availability of tumor material for central review processes and translational research projects - First recurrence after initial treatment with either radiotherapy and/or chemotherapy. - Enhancing recurrence on MRI scan. - Absence of any cardiovascular disorder. - Absence of any thrombotic or hemorrhagic issue. - Absence of known hypersensitivity. - No underlying or previous conditions that could interfere with treatment. - Normal hematological functions. - Normal liver function. - Normal renal function. - Age = 18 years. - WHO Performance status 0 - 2. - Women of childbearing potential (WOCBP) must be using an adequate method of contraception.
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:
- more than one line of chemotherapy. - radiotherapy within the three months prior to the diagnosis of progression - radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven - prior treatment with Bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors - invasive procedures within 4 weeks prior to randomization
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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recurrent grade II and grade III gliomas
MedDRA version: 9.1
Level: LLT
Classification code 10030288
MedDRA version: 9.1
Level: LLT
Classification code 10027744
MedDRA version: 9.1
Level: LLT
Classification code 10060971
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Intervention(s)
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Trade Name: AVASTIN
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Bevacizumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-
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Primary Outcome(s)
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Main Objective: Primary objective: activity of both the combination TMZ plus bevacizumab and TMZ alone in recurrent grade II or grade III glioma patients without 1p/19q co-deletion.
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Secondary Objective: Secondary objectives: safety, patient-oriented assessment of clinical benefit
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Primary end point(s): probability of survival at 1 year
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Secondary ID(s)
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2009-017422-39-NL
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26091
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date:
Contact:
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