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. Author manuscript; available in PMC: 2015 Dec 1.
Published in final edited form as: Phytochem Rev. 2014 Feb 5;13(4):793–810. doi: 10.1007/s11101-014-9337-5

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)
a

The number of human subjects is indicated in the parenthesis