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NCT01618747 Clinical Trial

An Observational Study of Avastin (Bevacizumab) in Patients With Glioblastoma Multiforme in First or Second Relapse

Glioblastoma Multiforme Clinical Trial

Official title:
A Single-arm, Open-label, Multicenter, Non-interventional Study to Assess Bevacizumab (Avastin) in Relapsed Glioblastoma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01618747
Other study ID # ML25550
Secondary ID
Status Completed
Phase N/A
First received June 11, 2012
Last updated February 26, 2018
Start date March 15, 2013
Est. completion date December 24, 2015

Study information
Verified date February 2018
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This single-arm, open-label, multicenter, observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with glioblastoma multiforme in first or second relapse. Data will be collected from eligible patients initiated on Avastin treatment according to local label for up to 3 years.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 24, 2015
Est. primary completion date December 24, 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adults patients, >/= 18 years of age

- Histologically confirmed glioblastoma multiforme in first or second relapse

Exclusion Criteria:

- Patients not qualifying for Avastin treatment as per local label

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Progression-free survival at 6 months approximately 3 years
Secondary Progression-free survival approximately 3 years
Secondary Time to disease progression approximately 3 years
Secondary Duration of objective response approximately 3 years
Secondary Overall survival approximately 3 years
Secondary Safety: Incidence of adverse events approximately 3 years
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