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

Phase 1

Conditions: Glioblastoma
MedDRA version: 14.1Level: PTClassification code 10018336Term: GlioblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2012-003138-17-IT

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 510

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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;Secondary Objective: To assess:<br>• overall survival as measured from randomization at PD1.<br>• progression free survival from randomization at PD1, to 2nd PD (PD2) (PFS2), and to 3rd PD (PD3) (PFS3).<br>• response rates (RRs), disease control rates (DCRs), and durations of response at PD2 and PD3.<br>• the safety of bevacizumab treatment across multiple lines of treatment and from randomization at PD1.<br>• HRQoL, neurocognitive function (NCF) and resource utilization <br>;Primary end point(s): Overall survival (OS);Timepoint(s) of evaluation of this end point: When 250 events have been observed

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - 2nd and 3rd line progression free survival (PFS)<br>- Response, duration of response and disease control rates in 2nd and 3rd line<br>- Safety<br>- Neurocognitive function, Health Related QoL, resource utilization ;Timepoint(s) of evaluation of this end point: at the time of the primary endpoint (when 250 events have been observed)