NCT01618747

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 13, 2012

Completed
9 months until next milestone

Study Start

First participant enrolled

March 15, 2013

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2015

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

June 11, 2012

Last Update Submit

February 26, 2018

Conditions

Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival at 6 months

    approximately 3 years

Secondary Outcomes (5)

  • Progression-free survival

    approximately 3 years

  • Time to disease progression

    approximately 3 years

  • Duration of objective response

    approximately 3 years

  • Overall survival

    approximately 3 years

  • Safety: Incidence of adverse events

    approximately 3 years

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with previously treated glioblastoma multiforme in first or second relapse

You may qualify if:

  • Adults patients, \>/= 18 years of age
  • Histologically confirmed glioblastoma multiforme in first or second relapse

You may not qualify if:

  • Patients not qualifying for Avastin treatment as per local label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Kaohisung, 83301, Taiwan

Location

Unknown Facility

Taipei, 00014, Taiwan

Location

Unknown Facility

Taipei, 11217, Taiwan

Location

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2012

First Posted

June 13, 2012

Study Start

March 15, 2013

Primary Completion

December 24, 2015

Study Completion

December 24, 2015

Last Updated

February 28, 2018

Record last verified: 2018-02

Locations

TW(3)