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

RTA 744-C-0401

This study assesses the tolerability, safety, efficacy and pharmacokinetics of RTA 744 in recurrent high-grade gliomas.

2005-11-30

2008-12-01

Early phase I

54

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.

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2024-02-02