A Safety Study of RTA 744 in Patients With Recurrent High-Grade Gliomas

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Reata Pharmaceuticals, Inc.

Criteria

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.