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Vandetanib and Etoposide

Phase 1

Gliosarcoma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Feb 20, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment49
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00613223Ph I Dose Escalation Trial of Vandetanib in Combo w Etoposide for Malignant GliomasPHASE1 COMPLETED 49Feb 1, 2008May 1, 2011Feb 20, 20131 United States
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Study Endpoints
Primary Endpoints
Safety, tolerability, biologic activity, & pharmacokinetic profile of vandetanib when used in combo w etoposide
6-month progression free survival
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Vandetanib and EtoposideEXPERIMENTALPatients will be stratified based on whether they are receiving an enzyme-inducing anti-epileptic drug (EIAED). The dose level of vandetanib will be increased in successive cohorts of subjects. Etoposide will be given daily at a dose of 50 mg/ day for 21 days followed by 7 days with no etoposide.
Interventions
NameTypeDescription
Vandetanib and EtoposideDRUGVandetanib will be given orally once day. Swallow tablet with 240 ml of non-carbonated water. Initial dose is 100 mg/day for stratum 1 \& 200 mg/day for stratum 2. Etoposide will be taken by mouth in capsule form at a flat dose of 50 mg/day for 1st 21 days of 28-day cycle. You will not take etoposide for following 7 days of the cycle.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients have baseline evaluations ≤14days prior to 1st dose of study drug unless otherwise specified * Patients with confirmed malignant glioma (MG) who are recurrence/relapse * Patients may not have stereotactic tumor biopsy \< 1 week or surgical resection or open biopsy \< 4...

Countries:United States
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