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

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ClinicalTrials.gov Identifier: NCT01618747
Recruitment Status : Unknown
Verified March 2013 by Hoffmann-La Roche.
Recruitment status was:  Not yet recruiting
First Posted : June 13, 2012
Last Update Posted : March 19, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Glioblastoma Multiforme

Study Design

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-arm, Open-label, Multicenter, Non-interventional Study to Assess Bevacizumab (Avastin) in Relapsed Glioblastoma
Study Start Date : May 2013
Estimated Primary Completion Date : May 2015
Estimated Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Progression-free survival at 6 months [ Time Frame: approximately 3 years ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: approximately 3 years ]
  2. Time to disease progression [ Time Frame: approximately 3 years ]
  3. Duration of objective response [ Time Frame: approximately 3 years ]
  4. Overall survival [ Time Frame: approximately 3 years ]
  5. Safety: Incidence of adverse events [ Time Frame: approximately 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with previously treated glioblastoma multiforme in first or second relapse

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01618747

Contact: Please reference Study ID Number: ML25550 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

Kaohisung, Taiwan, 83301
Taipei, Taiwan, 00014
Taipei, Taiwan, 11217
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01618747     History of Changes
Other Study ID Numbers: ML25550
First Posted: June 13, 2012    Key Record Dates
Last Update Posted: March 19, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents