Table 3.
Clinical studies on synthetic oleanane triterpenoids
Human Subjects | Objectives | Findings | Dose | Route | References |
---|---|---|---|---|---|
Patients with refractory/ relapsed AML (9)a | To find the correlation of CDDO and PPARγ on the effects of apoptosis and cell differentiation | No correlation | 0.6 – 75.0 mg/ m2/h | Continuous infusion | Tsao et al. (2010) |
Patients with advanced solid tumor refractory to standard treatments (7)a | To determine MTD for CDDO To determine pharmacokinetics and pharmacodynamics of CDDO |
MTD: 1 μM No antitumor activity |
0.6 – 38.4 mg/ m2/h | Continuous infusion | Speranza et al. (2012) |
Patients with advanced solid tumors refractory to standard treatments (47)a | To determine MTD and dose limiting toxicities for CDDO-Me To characterize pharmacokinetics and pharmacodynamics activity To assess antitumor activity |
MTD: 900 mg/d Complete tumor response | 5, 50 or 100 mg | Oral | Hong et al. (2012) |
Patients with moderate to severe CKD and type 2 diabetes (20)a | To assess the effects of CDDO-Me on eGFR To assess safety |
Increase in eGFR No serious adverse events |
25 or 75 mg | Oral | Pergola et al. (2011a) |
Patients with moderate to severe CKD and type 2 diabetes (227)a | To estimate the change in eGFR from baseline from CDDO-Me To assess safety |
Increase in eGFR maintained throughout 52 weeks Mild adverse events |
25, 75 or 150 mg | Oral | Pergola et al. (2011b) |
The number of human subjects is indicated in the parenthesis