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AZD2014

Phase 2

Neurofibromatosis 2 | Small molecule | Other |AstraZeneca PLC|Last Updated: Jun 13, 2022

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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02831257AZD2014 In NF2 Patients With Progressive or Symptomatic MeningiomasPHASE2 COMPLETED 18Aug 31, 2016Oct 1, 2020Jun 13, 20222 United States
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Study Endpoints
Primary Endpoints
Radiographic Response Rate for Target Meningioma
up to 24 months

Number of Target Meningiomas with a Decrease in Tumor Volume of at least 20% Compared with Baseline

Secondary Endpoints
Median Progression-free Survival (PFS)
From date of registration until the date of first documented progression assessed up to 24 months
Progression Free Survival at 6 Month
6 months of treatment
Radiographic Response Rate for Non-target Meningiomas
up to 24 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD2014EXPERIMENTAL18 patients will be enrolled in this study in a single stage. * AZD2014 orally, 2 times a day on 2 consecutive day out of every 7 days. * One cycle will consist of 28 days (1 cycle = 28 days).
Interventions
NameTypeDescription
AZD2014DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Patients must have a confirmed diagnosis of neurofibromatosis 2 by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF2 gene. * Participants must have progressive or symptomatic meningioma. NOTE 1: Hi...

Countries:United States
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