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Avastin

Phase 2

Neuroendocrine Carcinoma | Small molecule | Oncology |Novartis AG|Last Updated: Jul 18, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00607113Avastin (Bevacizumab) and RAD001 (Everolimus) in Advanced Low or Intermediate Grade Neuroendocrine CarcinomaPHASE2 COMPLETED 41Jan 1, 2008Oct 1, 2011Jul 18, 20131 United States
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Study Endpoints
Primary Endpoints
Net Change Relative to Baseline in Tumor Blood Flow
Baseline to end of Cycle 3 (63 days)

Tumor blood flow (ml/min/100gm) determined by functional computed tomography (CT). Functional computed tomography (CT) at baseline, after first and third cycles (21 day cycles). Change (percentage) calculated as tumor blood flow measured at baseline compared to tumor blood flow measurement taken at end of Cycle 1, week 3 (21 days), and again at end of Cycle 3, Week 9 (63 days).

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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AvastinEXPERIMENTALCycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV)
Avastin + RAD001EXPERIMENTALCycle 2: Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 3 weeks
RAD001EXPERIMENTALCycle 1 (First 3 weeks of study)- RAD001 10 mg orally daily for 21 Days
Interventions
NameTypeDescription
AvastinDRUG15 mg/kg By Vein Over 90 Minutes Every 21 Days
RAD001DRUG10 mg By Mouth Daily For 21 Days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must have histologically or cytologically confirmed low or intermediate grade neuroendocrine carcinoma. Patients with neuroendocrine tumors associated with MEN1 syndrome will be eligible. 2. Patients must have at least one measurable site of disease according to Resp...

Countries:United States
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