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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
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01618747
First received: June 11, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose
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
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 ]

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

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)

  Eligibility

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
  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 ClinicalTrials.gov identifier: NCT01618747

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

Locations
Taiwan
Recruiting
Kaohisung, Taiwan, 83301
Recruiting
Taipei, Taiwan, 00014
Recruiting
Taipei, Taiwan, 11217
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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
Study First Received: June 11, 2012
Last Updated: March 18, 2013

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

ClinicalTrials.gov processed this record on May 22, 2017