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Bevacizumab

Phase 4FDA approved

Solid Tumors | Monoclonal antibody | Oncology |Amgen Inc.|Trials Updated: Nov 19, 2014

Bevacizumab development status

FDA approval on record Feb 26, 2004 as Avastin
Approval holderGenentech
ApplicationBLA125085
Highest phase Phase 4 run by Hoffmann-La Roche (NCT01588184)
Phase scored for AMGNPhase 1
Registered trials 322+ across 132 sponsors since Nov 2004

Label indication Avastin is a vascular endothelial growth factor inhibitor indicated for the treatment of: Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first- or second-line treatment. FDA label

Bevacizumab target and mechanism

Molecular targetVEGFA
Target classInhibitor
ModalityMonoclonal antibody

Also known as Avastin

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Bevacizumab clinical trials

Bevacizumab · 1 trial · 1 indication

Phase 1 1
NCT00586443BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)Solid Tumors
COMPLETED56 Analytics
PHASE1COMPLETED
BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)
Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

To determine the MTD/recommended phase II regimen and evaluate safety of panitumumab added to RAD001 plus bevacizumab in adult patients with advanced solid tumors.
Every cycle (28-days)

Secondary Endpoints

To preliminarily describe any clinical activity (PR, CR or duration of SD) associated with this regimen
Every cycle (28-days)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
IOTHERThis is a Phase I safety study. There is only one arm.

Interventions

NameTypeDescription
bevacizumab, everolimus, panitumumabDRUGCohort # subjects Bevacizumab Everolimus Panitumumab * 3 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 3.6 mg/kg IV Q2 weeks * 2 3-6 5 mg/kg IV Q2 weeks 5 mg PO QoD 4.8 mg/kg IV Q2 weeks * 1 3-6 10 mg/kg IV Q2 weeks 5 mg PO QD 4.8 mg/kg IV Q2 weeks 1. 3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 4.8 mg/kg IV Q2 weeks 2. 3-6 10 mg/kg IV Q2 weeks 10 mg PO QD 6 mg/kg IV Q2 weeks 3a 10 RPTD\* RPTD\* RPTD\* 3b 10 RPTD\*\* RPTD\*\* RPTD\*\* * Panitumumab and RAD001 started on Day 1, bevacizumab started on Day 15. \*\*Bevacizumab and RAD001 started on Day 1, panitumumab started on Day 15.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective. Disease must be measurable or evaluable by RECIST criteria. * Patients must not have had ra...

Countries:United States
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Competitive Landscape -Other Solid Tumors 10 trials (matched to "Solid Tumors")

Frequently asked questions about Bevacizumab

What is bevacizumab used for?

Bevacizumab is being studied for the treatment of solid tumors. It is an investigational monoclonal antibody in Phase 1 clinical development. It has not been established as a treatment for any condition outside of clinical research.

What does bevacizumab target?

Bevacizumab targets VEGFA, vascular endothelial growth factor A. It is classified as an inhibitor of this target. By binding VEGFA, the monoclonal antibody is designed to interfere with VEGF-mediated signaling in solid tumors.

Who is developing bevacizumab?

Amgen Inc. (ticker AMGN) is the developer of bevacizumab. The company is responsible for the clinical development program evaluating the monoclonal antibody in solid tumors.

What phase is bevacizumab in?

Bevacizumab is in Phase 1 clinical development. The program includes one completed Phase 1 trial with no active trials currently listed. It is investigational and has not been approved by the FDA for any indication.

What clinical trials is bevacizumab in?

Bevacizumab has been evaluated in the Phase 1 BEP Study (NCT00586443), titled "BEP Study Phase I (Bevacizumab, Everolimus, Panitumumab)." The trial enrolled 56 participants with solid tumors in the United States and is completed. It was an uncontrolled study without randomization or blinding.

Is bevacizumab the same as Avastin?

Bevacizumab is also known by the names everolimus, panitumumab, and Avastin. These alternative names refer to the same drug asset in this development program.