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Bevacizumab

Phase 1

Solid Tumors | Small molecule | Oncology |Amgen Inc.|Last Updated: Nov 19, 2014

Target and mechanism

ModalitySmall molecule

Also known as bevacizumab, everolimus, panitumumab, Avastin

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

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 9 trials (matched to "Solid Tumors")