CF102 for the treatment of hepatocellular carcinoma: a phase I/II, open-label, dose-escalation study.

ABSTRACT:

Background

The A(3) adenosine receptor (A(3)AR) is overexpressed in the tumor and in the peripheral blood mononuclear cells of patients with hepatocellular carcinoma (HCC). The orally active drug candidate CF102, an A(3)AR agonist, induces apoptosis of HCC cells via deregulation of the Wnt signaling pathway. In this open label phase I/II trial, the safety and clinical effects of CF102 were assessed in patients with advanced unresectable HCC.

Methods

The primary objectives of this trial were to examine the safety and pharmacokinetic (PK) behavior of CF102 given orally (1, 5, and 25 mg BID) in 28-day cycles. Evaluation of anti-tumor effects and the utilization of A(3)AR as a biological predictive marker of response to CF102 were the secondary objectives.

Results

Eightee

SUBMITTER: Stemmer SM 

PROVIDER: S-EPMC3556251 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature