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

• Register: EUCTR
• Last refreshed on: 31 January 2017
• Main ID: EUCTR2012-003138-17-IT
• Date of registration: 03/05/2013
• Prospective Registration: Yes
• Primary sponsor: F. Hoffmann-La Roche Ltd
• Public title: 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
• Scientific title: 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: 25/06/2013
• Target sample size: 510
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003138-17
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Albania, Austria, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Croatia, Denmark, Egypt, Estonia, Finland, France, Greece, India, Ireland, Italy, Latvia, Lithuania, Macedonia, the former Yugoslav Republic of, Netherlands, Norway, Portugal, Serbia, Spain, Sweden, Turkey, United Kingdom, Uruguay

Contacts

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

• Name: Trial Information Support Line-TISL
• Affiliation: F.Hoffmann-La Roche Ltd

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Glioblastoma
MedDRA version: 14.1 Level: PT Classification code 10018336 Term: Glioblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Intervention(s)

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

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: When 250 events have been observed

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

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

Primary end point(s): Overall survival (OS)

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: at the time of the primary endpoint (when 250 events have been observed)

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

Secondary ID(s)

MO28347

2012-003138-17-AT

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd