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trofosfamide, idarubicin, etoposide

Phase 3

Soft Tissue Sarcoma | Small molecule | Oncology |Solid Biosciences Inc.|Last Updated: Nov 8, 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
RandomizedNO_TREATMENT_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment195
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00876031Trial for Localised High-risk Rhabdomyosarcoma and Rhabdomyosarcoma-like Soft Tissue SarcomaPHASE3 COMPLETED 195Jul 1, 2009Jun 30, 2022Nov 8, 202287 Austria, Germany +3
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Study Endpoints
Primary Endpoints
event free survival (EFS)
3 years
Secondary Endpoints
Overall survival
5 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
O-TIEEXPERIMENTALoral maintenance therapy with trofosfamide, idarubicin, and etoposide
controlNO_INTERVENTION -
Interventions
NameTypeDescription
trofosfamide, idarubicin, etoposideDRUGoral maintenance therapy for 6 months
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Eligibility Criteria
Age Range6 Months — 21 Years
SexALL
Healthy VolunteersNo
Study Sites87

Inclusion Criteria: * written informed consent for registration, randomisation, data collection/transfer, and tumour material asservation available * pathologically (including molecular pathology) proven diagnosis of rhabdomyosarcoma (RMS) or RMS-like soft tissue sarcoma (STS) and tumour material a...

Countries:AustriaGermanyPolandSwedenSwitzerland
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