Clinical trial · Interventional
A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas
A Phase I Dose-finding and Pharmacokinetic Study of Intravenous RTA 744 Injection in Patients With Recurrent or Refractory Anaplastic Astrocytoma (AA), Anaplastic Oligodendroglioma (AO), Anaplastic Mixed Oligo-astrocytoma (AOA), Glioblastoma Multiforme (GBM) or Gliosarcoma (GS), With or Without Concurrent Treatment With Enzyme-inducing Anticonvulsant Therapy
NCT00526812CI-TRIAL-00090238completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RTA 744 | Drug | — | UNRESOLVED |
| RTA 744 injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A (RTA 744)
- description
- Receive study drug for three consecutive days, Cycle repeated every 21 days.
- interventionNames
- Drug: RTA 744
- type
- EXPERIMENTAL
- label
- Group C (RTA 744 Injection)
- description
- Receive study drug once a week for four consecutive weeks. Repeat cycle every 5 weeks.
- interventionNames
- Drug: RTA 744 injection
Primary outcomes (1)
- measure
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 allowed if there is current histologic proof of progression to a diagnosis of AA, AO, AOA, GBM or GS * Unequivocal evidence of recurrence or progression by neuroimaging procedure. * Surgical resection at least 2 weeks prior to enrollment and must have completely recovered from the side effects. * A stable dose of steroids for at least 7 days prior to obtaining the Gd-MRI of the brain. * Previously implanted Gliadel® wafer may be eligible. * Karnofsky Performance Status (KPS) of ≥ 60. * Laboratory parameters: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L, Hemoglobin (Hgb) ≥ 9 g/dl, Platelets ≥ 100 x 109/L, AST and ALT ≤ 3.0 x Upper Limit of Normal (ULN), Serum bilirubin ≤ 1.5 x ULN, Serum creatinine ≤ 1.5 x ULN and 24 hour creatinine clearance ≥ 50 ml/min * Life expectancy of greater than 12 weeks. * Written informed consent obtained. Exclusion Criteria: * Pregnancy or breast feeding, or adults of reproductive potential not employing an effective method of birth control * Total urinary protein in 24 hours urine collection \> 500 mg * Any concurrent severe and/or uncontrolled medical conditions which could compromise participation in the study. * Impaired cardiac function, other significant prior cardiac disease or arrhythmia of any * A history of CHF or arrhythmias. * Therapeutic doses of warfarin sodium (Coumadin®). * Prior or concurrent therapy, or not recovered from the toxic effects of such therapy: investigational drugs, chemotherapy, metronomic daily dosing of chemotherapy agents, biologic, immunotherapy or cytostatic agents within 4 weeks prior to study entry; radiation therapy within 2 weeks prior to study entry, any medication known to cause QT interval prolongation * Any surgery other than resection of a brain tumor within 2 weeks prior to enrollment. * A contraindication to MRI imaging.
References
Publications (1)
- DERIVEDConrad CA, Hsu SH, Thapar N, Maher EA, Cloughesy TF, Colman H, Gilbert MR, Puduvalli VK, Madden T, Priebe W. Phase I trial and pharmacokinetic study of berubicin (RTA 744) in patients with recurrent or refractory high-grade gliomas. Neurooncol Adv. 2026 Jul 31;8(1):vdag150. doi: 10.1093/noajnl/vdag150. eCollection 2026 Jan-Dec. PMID 42569309