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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Glioblastoma

Thank you

Trial Information

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


Inclusion Criteria:



- Adult patients >/= 18 years of age

- Newly diagnosed, histologically confirmed glioblastoma not previously treated with
chemotherapy or radiotherapy

- Female patients of childbearing potential and fertile male patients must agree to use
effective contraception as defined by protocol for the duration of the study and for
at least 6 months following the last administration of study drugs

- Karnofsky performance status (KPS) >/= 60

Exclusion Criteria:

- Any prior chemotherapy for glioblastoma 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

- Treatment with any other investigational drug within 28 days or 2 investigational
agent half-lives (whichever is longer) prior to first study treatment

- Inadequate hematological, renal or liver function

- Inadequately controlled hypertension

- Prior history of gastrointestinal perforation or abscess

- Clinically significant cardiovascular disease, NYHA >/= Grade II congestive heart
failure, or serious cardiac arrhythmia uncontrolled by medication or potentially
interfering with protocol treatment

- History or evidence of central nervous system disease unrelated to cancer unless
adequately treated with standard medical therapy

- History or evidence of inherited bleeding diathesis or significant coagulopathy at
risk of bleeding

- Serious non-healing wound, active ulcer, or untreated bone fracture

- Known hypersensitivity to any component of Avastin/placebo or any of the study drugs

- Active infection requiring intravenous antibiotics at start of study treatment

- Other malignancy within 5 years prior to study enrolment, except for carcinoma in
situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or
ductal carcinoma in situ treated with curative intent

- Pregnant or lactating women

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Overall survival, defined as time from randomization (at PD1) to death from any cause

Outcome Time Frame:

approximately 6 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Ireland: Ministry of Health

Study ID:

MO28347

NCT ID:

NCT01860638

Start Date:

August 2013

Completion Date:

May 2018

Related Keywords:

  • Glioblastoma
  • Glioblastoma
  • Disease Progression

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