NCT01588184|CompletedPhase 4Results

An Extension Study to Provide Continued Bevacizumab Therapy to Participants With Solid Tumors Who Were Previously Enrolled in a Roche/Genentech Sponsored Study

A Single Arm, Open Label Multicentre Extension Study of Bevacizumab in Patients With Solid Tumours on Study Treatment With Bevacizumab, at the End of A F. Hoffmann-La Roche and/or Genentech Sponsored Study

Hoffmann-La Roche ClinicalTrials.gov

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2 other identifiers

MO257572011-002009-31

Study Type

interventional

Target

Locations

20 countries

Sites

Timeline

RegisteredApr 2012

StartedJul 2012

CompletionSep 2019

Brief Summary

This single-arm, open-label, multicenter extension study will provide continued bevacizumab therapy to participants with solid tumors who were previously enrolled in a Roche/Genentech sponsored study and who derived benefit from the bevacizumab therapy. Participants will receive the same dose and regimen of bevacizumab as used in the previous parent trial and continue this treatment until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P50-P75 for phase_4

Timeline

Completed

Started Jul 2012

Longer than P75 for phase_4

Geographic Reach

20 countries

72 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

7.2 years study duration

First Submitted

Initial submission to the registry

April 26, 2012

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed

2 months until next milestone

Study Start

First participant enrolled

July 13, 2012

Completed

7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

November 5, 2020

Completed

Last Updated

November 5, 2020

Status Verified

October 1, 2020

Enrollment Period

7.2 years

First QC Date

April 26, 2012

Results QC Date

September 11, 2020

Last Update Submit

October 15, 2020

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (1)

Percentage of Participants With Adverse Events
An adverse event (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product.
Baseline up to approximately 81 months

Secondary Outcomes (2)

Progression Free Survival (PFS)
Baseline up to approximately 81 months
Overall Survival (OS)
Baseline up to approximately 81 months