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RTA 744

Phase 1

Glioma | Small molecule | Oncology |Biogen Inc.|Last Updated: May 28, 2025

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment54
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00526812A Safety Study of RTA 744 in Patients With Recurrent High-Grade GliomasPHASE1 COMPLETED 54Nov 30, 2005 -May 28, 20254 United States
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Study Endpoints
Primary Endpoints
To determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of RTA 744 Injection in the patient population studied and to determine the qualitative and quantitative toxic effects of RTA 744 Injection.
at end of first cycle for each patient cohort
Secondary Endpoints
To characterize the multiple-dose pharmacokinetics of RTA 744 and to document any potential antitumor activity of RTA 744 in those patients with measurable disease.
end of study
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group A (RTA 744)EXPERIMENTALReceive study drug for three consecutive days, Cycle repeated every 21 days.
Group C (RTA 744 Injection)EXPERIMENTALReceive study drug once a week for four consecutive weeks. Repeat cycle every 5 weeks.
Interventions
NameTypeDescription
RTA 744DRUGAqueous solution added to 10%D/W and infused over 2 hours on three consecutive days. 5 mg vials contain 1 mg/ml.
RTA 744 injectionDRUGAqueous solution in 1mg/ml. Doses are escalated. Drug is infused intravenously over 2 hours one day a week for four consecutive weeks.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Prior histologically confirmed anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic mixed oligo-astrocytoma, glioblastoma multiforme, or gliosarcoma, for whom no other effective therapy is available. * A prior histologic diagnosis of a lower grade of glioma is allo...

Countries:United States
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