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vandetanib and dasatinib

Phase 1

Diffuse Intrinsic Pontine Glioma | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Apr 6, 2015

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 Enrollment25
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00996723Clinical Trial Evaluating the Combination of Vandetanib and Dasatinib During and After Radiation Therapy (RT) in Children With Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)PHASE1 COMPLETED 25Oct 1, 2009Jun 1, 2014Apr 6, 20151 United States
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Study Endpoints
Primary Endpoints
To estimate the maximum tolerated dose (MTD) of the combination of vandetanib and dasatinib administered concurrently with RT in pediatric research participants with newly diagnosed DIPG
April 2012
Secondary Endpoints
To determine the toxicities associated with the chronic use of vandetanib and dasatinib
July 2012
To characterize the pharmacokinetics of vandetanib and dasatinib in pediatric research participants
July 2012
To evaluate the influence of specific polymorphisms (e.g., CYP3A4/5) on the pharmacokinetics of vandetanib and dasatinib administered in combination
July 2012
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1OTHER -
Interventions
NameTypeDescription
vandetanib and dasatinibDRUGTwo oral investigational agents (vandetanib \[VEGFR2, RET, and EGFR inhibitor\] and dasatinib \[bcr-abl, PDGFRA and B, src, lck, yes, and c-kit inhibitor\] will be administered during and after local RT, which is the only standard therapy for children with DIPG.
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Eligibility Criteria
Age Range18 Months — 21 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age must be ≥ 18 months and \< 21 years 2. Diagnosis of DIPG or high-grade glioma originating from the brainstem. 3. Lansky (for research participants ≤ 16 years) or Karnofsky (for research participants \> 16 years) performance score ≥ 40 at the time of study enrollment 4. Ad...

Countries:United States
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