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RTA 744

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

RTA 744 · 1 trial · 1 indication

Phase 1 1
NCT00526812A Safety Study of RTA 744 in Patients With Recurrent High-Grade GliomasGlioma
COMPLETED54 Analytics
PHASE1COMPLETED
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas
GliomaUnlock trial analytics

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 to 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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Frequently asked questions about RTA 744

What is RTA 744 used for?

RTA 744 is an investigational small molecule being developed for the treatment of glioma, a type of brain tumor. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and efficacy in patients.

Who makes RTA 744?

RTA 744 is being developed by Biogen Inc., a biotechnology company traded on the NASDAQ under the ticker symbol BIIB. The company is conducting clinical trials to evaluate the safety and potential efficacy of this investigational drug in patients with recurrent high-grade gliomas.

What phase is RTA 744 in?

RTA 744 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by the FDA or other regulatory agencies. The Phase 1 trial is designed to assess the safety, tolerability, and dosing of the drug in patients with recurrent high-grade gliomas.

What clinical trials is RTA 744 in?

RTA 744 has been studied in one completed Phase 1 clinical trial with the identifier NCT00526812, titled 'A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas.' The trial enrolled 54 participants in the United States and included adults aged 18 years and older.

Is RTA 744 FDA approved?

No, RTA 744 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial (NCT00526812) was a safety study in patients with recurrent high-grade gliomas, but the drug has not yet received regulatory approval for any indication.