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NovoTTF-100A

Phase 3

Recurrent Glioblastoma Multiforme | Unknown | Oncology |NovoCure Limited|Last Updated: May 1, 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
RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment236
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00379470Effect of NovoTTF-100A in Recurrent Glioblastoma Multiforme (GBM)PHASE3 COMPLETED 236Sep 1, 2006Jan 1, 2011May 1, 201225 United States, Austria +5
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Study Endpoints
Primary Endpoints
Overall Survival
2 years from initiation of accrual
Secondary Endpoints
Progression free survival at 6 months (PFS6)
2 years from initiation of accrual
Median Time to Disease Progression (TTP)
2 years from initiation of accrual
% 1-year survival
2 years from initiation of accrual
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Best Standard of CareACTIVE_COMPARATORPatients randomized to the BSC group will be treated with one chemotherapy according to the BSC practiced at each center.
NovoTTF-100AEXPERIMENTAL -
Interventions
NameTypeDescription
NovoTTF-100ADEVICEmultiple four-week courses of continuous NovoTTF-100A treatment
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Pathological evidence of GBM using WHO classification criteria. * \> 18 years of age. * Not a candidate for further radiotherapy or additional resection of residual tumor. * Patients with disease progression (by Macdonald criteria i.e., \> 25% or new lesion) documented by CT o...

Countries:United StatesAustriaCzechiaFranceGermanyIsraelSwitzerland
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