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Vandetanib

Phase 1

Anal, Colon, and Rectal Cancers | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 16, 2012

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00532909Phase I Vandetanib Plus Capecitabine, Oxaliplatin and Bevacizumab for Metastatic Colorectal CancerPHASE1 COMPLETED 13Jul 1, 2006May 1, 2010Jul 16, 20121 United States
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Study Endpoints
Primary Endpoints
Maximum tolerated dose of vandetanib in combination with capecitabine, oxaliplatin and bevacizumab
Following treatment
Secondary Endpoints
Effect of vandetanib on the pharmacokinetics (PK) of capecitabine and oxaliplatin
During and following treatment
Effects of this treatment on tumor remission, progression free survival, and overall survival of patients
Following treatment
Dose limiting toxicities associated with the combination
During and following treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
VandetanibDRUG100mg or 300mg By mouth every day continuous
CapecitabineDRUGDosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
OxaliplatinDRUGdosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
BevacizumabDRUGDosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of signed informed consent. * Female and or male age 18 years and over. * Negative pregnancy test for women of childbearing potential. * Histologically or cytologically confirmed adenocarcinoma of the colon or rectum. * Patients with a history of colorectal adenocarc...

Countries:United States
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