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. |
Register:
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EUCTR |
Last refreshed on:
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3 July 2017 |
Main ID: |
EUCTR2012-003138-17-GR |
Date of registration:
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25/06/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Clinical study evaluating if the patient is better and lives longer if bevacizumab is continued to be added to the standard treatment for worsening brain cancer
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Scientific title:
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A double-blind, placebo-controlled, randomized, Phase IIIb trial evaluating the efficacy and safety of standard of care (SOC) +/-continuous bevacizumab treatment following progression of disease (PD) in patients with glioblastoma (GBM) after first (1st)-line treatment with radiotherapy, temozolomide and bevacizumab |
Date of first enrolment:
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11/07/2013 |
Target sample size:
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510 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003138-17 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Albania
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Austria
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Bosnia and Herzegovina
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Brazil
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Bulgaria
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Canada
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China
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Croatia
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Denmark
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Egypt
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Estonia
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Finland
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France
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Greece
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India
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Ireland
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Italy
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Latvia
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Lithuania
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Macedonia, the former Yugoslav Republic of
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Netherlands
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Norway
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Portugal
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Serbia
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Spain
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Sweden
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Turkey
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United Kingdom
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Uruguay
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F.Hoffmann-La Roche Ltd |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Have provided written informed consent.
• Age = 18 years .
• Karnofsky performance status (KPS) = 60.
• Newly diagnosed GBM
• Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days and = 49 days following the last surgical procedure.
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 398 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 112
Exclusion criteria: • Any prior chemotherapy for GBM and low grade astrocytomas.
• Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
• Prior or current anti-angiogenic treatment (i.e. anti-VEGF or VEGFR therapies or tyrosine kinase inhibitors).
• Evidence of recent brain haemorrhage
• Acute cardiac disease
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Glioblastoma MedDRA version: 16.0
Level: PT
Classification code 10018336
Term: Glioblastoma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Trade Name: Avastin Product Name: Bevacizumab Product Code: RO4876646/F02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Current Sponsor code: RO4876646 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: To assess: • overall survival as measured from randomization at PD1. • progression free survival from randomization at PD1, to 2nd PD (PD2) (PFS2), and to 3rd PD (PD3) (PFS3). • response rates (RRs), disease control rates (DCRs), and durations of response at PD2 and PD3. • the safety of bevacizumab treatment across multiple lines of treatment and from randomization at PD1. • HRQoL, neurocognitive function (NCF) and resource utilization
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Timepoint(s) of evaluation of this end point: When 250 events have been observed
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Main Objective: • To assess the efficacy of continuous treatment with bevacizumab + SOC vs. placebo + SOC beyond 1st PD (PD1) as measured by overall survival (OS) from randomization at PD1
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Primary end point(s): Overall survival (OS)
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Secondary Outcome(s)
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Secondary end point(s): - 2nd and 3rd line progression free survival (PFS)
- Response, duration of response and disease control rates in 2nd and 3rd line
- Safety
- Neurocognitive function, Health Related QoL, resource utilization
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Timepoint(s) of evaluation of this end point: at the time of the primary endpoint (when 250 events have been observed)
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Secondary ID(s)
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2012-003138-17-AT
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MO28347
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd
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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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