An Observational Study of Avastin (Bevacizumab) in Patien... | NCT01618747

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

NCT01618747

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Feb 28, 2018Actual

Enrollment

20Estimated

Phase

Not provided

Conditions

Glioblastoma Multiforme

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 15, 2013Actual

Primary Completion Date

Dec 24, 2015Actual

Completion Date

Dec 24, 2015Actual

First Submitted Date

Jun 11, 2012

First Submission Date that Met QC Criteria

Jun 12, 2012

First Posted Date

Jun 13, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 26, 2018

Last Update Posted Date

Feb 28, 2018Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Cohort

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression-free survival at 6 months		approximately 3 years

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival		approximately 3 years
Time to disease progression		approximately 3 years
Duration of objective response

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with previously treated glioblastoma multiforme in first or second relapse

Sampling Method

Probability Sample

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D005909	Glioblastoma

Ancestor Terms

ID	Term
D001254	Astrocytoma
D005910	Glioma
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Kaohisung		83301	Taiwan