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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 : Completed
First Posted : June 13, 2012
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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 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
Actual Study Start Date : March 15, 2013
Actual Primary Completion Date : December 24, 2015
Actual Study Completion Date : December 24, 2015

Resource links provided by the National Library of Medicine

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

Group/Cohort
Cohort



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 ]


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
Criteria

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

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


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

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: February 28, 2018
Last Verified: February 2018

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