This study assesses the tolerability, safety, efficacy and pharmacokinetics of Bardoxolone methyl (RTA 402) in advanced solid tumors and lymphoid malignancies.
Bardoxolone methyl (RTA 402) is a synthetic triterpenoid that has demonstrated significant in vivo single agent anti-cancer activity. This is an open-label phase I dose-escalation study of Bardoxolone methyl (RTA 402) administered orally for the first 21 days of a 28-day cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Case Western Reserve University
Cleveland, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
To determine the dose-limiting toxicity, maximum tolerated dose, and recommended phase II dose of Bardoxolone methyl Capsules
Time frame: 28 day cycles, with a maximum of 18 cycles (18 months)
To characterize the pharmacokinetics of Bardoxolone methyl in this patient population.
Time frame: 28 day cycles, with a maximum of 18 cycles (18 months)
To document any preliminary antitumor activity.
Time frame: 28 day cycles, with a maximum of 18 cycles (18 months)
To determine the in vivo molecular and biological effects.
Time frame: 28 day cycles, with a maximum of 18 cycles (18 months)
To correlate the biological activity of RTA 402 with drug concentration in plasma and blood cellular elements.
Time frame: 28 day cycles, with a maximum of 18 cycles (18 months)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.