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

Phase 4

Completed

• Conditions: Neoplasms
• Interventions: Drug: Bevacizumab

• Registration Number: NCT01588184
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-26
• Study First Posted: 2012-04-30
• Study Start: 2012-07-13
• Primary Completion: 2019-09-27
• Study Completion: 2019-09-27
• Results First Submitted: 2020-09-11
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-15
• Last Update Submitted: 2020-10-15
• Results First Posted: 2020-11-05
• Last Update Posted: 2020-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Colorectal Cancer	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Breast Cancer	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Ovarian Cancer or Peritoneal Carcinoma	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Glioblastoma Multiforme	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Renal Cell Carcinoma	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.
Non-Squamous, Non-Small Cell Lung Cancer	Bevacizumab	Participants will receive bevacizumab until progression of disease or unacceptable toxicity, withdrawal of consent or death whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	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 Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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.
Overall Survival (OS)	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.

Trial Locations

Locations (73)

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

Hospital Araujo Jorge; Departamento de Ginecologia E Mama; 🇧🇷 Goiania, GO, Brazil

Hospital Sao Lucas - PUCRS; 🇧🇷 Porto Alegre, RS, Brazil

Hospital de Cancer de Barretos; 🇧🇷 Barretos, SP, Brazil

Instituto do Cancer do Estado de Sao Paulo - ICESP; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Perola Byington; 🇧🇷 Sao Paulo, SP, Brazil

Hospital A. C. Camargo; Oncologia; 🇧🇷 Sao Paulo, SP, Brazil

Hospital Sao Jose; 🇧🇷 São Paulo, SP, Brazil

MBAL Serdika EOOD; 🇧🇬 Sofia, Bulgaria

University Health Network; Princess Margaret Hospital; Medical Oncology Dept; 🇨🇦 Toronto, Ontario, Canada

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