Phase I Trial of Siliphos in Patients With Advanced Hepatocellular Carcinoma
Milk thistle (MT) has been historically used to treat patients with liver diseases, and has
been shown to have antioxidant, anti inflammatory, and hepatoprotective properties. It may
also have direct anticancer effects through inhibition of growth factors and promotion of
cell cycle arrest. MT has been shown to improve LFTs in several studies of patients with
cirrhosis. To our knowledge, there have been no published trials evaluating the clinical
efficacy of MT in advanced HCC. We therefore propose a phase I study to identify the maximum
tolerated dose (MTD) of silybinphosphatidylcholine (a commercially available preparation
with increased bioavailability), in patients with advanced HCC. We will use a traditional
dose escalation, open label design with a study intervention period of 3 months, followed by
one year of observation, with a maximum total of 30 subjects, evaluating a dose range
between 1 to 12 gm Siliphos. The data obtained from this study will be utilized in the
future to evaluate MT efficacy in reducing liver function tests in advanced HCC, which will
have significant implications in its use as a potential adjunctive agent in patients with
currently limited treatment options.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The maximum tolerated dose of siliphos in patients with advanced hepatocellular carcinoma
Weeks 1, 3, 6, 9, and 12
Yes
Abby Siegel, MD, MS
Principal Investigator
Columbia University
United States: Food and Drug Administration
AAAE7604
NCT01129570
February 2010
February 2015
Name | Location |
---|---|
Columbia University Medical Center | New York, New York 10032 |