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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2013 by Hoffmann-La Roche
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 ] [ 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
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

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

No publications provided

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
Health Authority: Taiwan: Taiwan Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 29, 2014