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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2013 by Hoffmann-La Roche.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: June 11, 2012
Last updated: March 18, 2013
Last verified: March 2013
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.

Glioblastoma Multiforme

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single-arm, Open-label, Multicenter, Non-interventional Study to Assess Bevacizumab (Avastin) in Relapsed Glioblastoma

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Progression-free survival at 6 months [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Time to disease progression [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Duration of objective response [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01618747

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 Identifier: NCT01618747     History of Changes
Other Study ID Numbers: ML25550 
Study First Received: June 11, 2012
Last Updated: March 18, 2013
Health Authority: Taiwan: Taiwan Food and Drug Administration

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 processed this record on December 06, 2016