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Completed

NCT Number: NCT01588184

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

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.

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Key information

Conditions

Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

A.Ö. LKH; Abt. für Lungenkrankheiten, Steyr, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant is treated with bevacizumab at the end of the Roche/Genentech sponsored parent trial and continues to have benefit as judged by the investigator
  • Eligible for continuation of bevacizumab treatment at the end of a parent trial, according to parent trial protocol
  • Able to comply with this extension study protocol (MO25757)

Exclusion criteria

  • Evidence of disease progression assessed according to parent trial protocol during the screening phase for this extension study
  • Evidence of any adverse event potentially attributable to bevacizumab, for which the local label recommends permanent discontinuation
  • A treatment interruption with bevacizumab of more than 42 days since the last administration of bevacizumab in the parent trial
  • Evidence of any other disease that would put the participant at high risk for treatment-related complications

Treatment and study plan

Bevacizumab

Drug

Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).

Other names: Avastin

Primary outcomes

  1. Percentage of Participants With Adverse Events

    Time frame: Baseline up to approximately 81 months

    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.

Secondary outcomes

  1. Progression Free Survival (PFS)

    Time frame: Baseline up to approximately 81 months

    Progression free survival is defined as the time from first dose of Bevacizumab in this extension trial (E-trial) to the time of first documented disease progression or death due to any cause, whichever occurs first.

  2. Overall Survival (OS)

    Time frame: Baseline up to approximately 81 months

    Overall survival time is defined as the time from first dose of Bevacizumab in the E-trial to death from any cause.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Apr 30, 2012
Registry last updated
Nov 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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