Alaunos Therapeutics trial of darinaparsin in liver cancer ends after first stage

A Phase 2 trial testing darinaparsin, also known as ZIO-101, in patients with advanced hepatocellular carcinoma has been listed as terminated, according to its clinicaltrials.gov record (NCT00423306). The registry states the study closed after Stage 1, with 15 of 40 planned patients treated, due to lack of treatment response, and that the criteria to proceed to Stage 2 were not met.¹

The trial, sponsored by Alaunos Therapeutics, began in May 2007, and both primary completion and study completion are listed as August 9, 2008. The record was first posted January 18, 2007, and last updated September 30, 2026.¹

The single-arm, non-randomized study enrolled 15 participants who received darinaparsin at 420 mg/m2 given twice weekly for three weeks, followed by one week of rest, for up to 6 months.¹ The trial's primary outcome was response rate measured over a 6-month time frame, with overall and progression-free survival and toxicities tracked as secondary outcomes.

Eligible patients needed histologically confirmed HCC or clinical evidence that included liver masses at least 2cm in longest diameter with AFP levels of 500 ng/mL or more in the context of cirrhosis or chronic HBV or HCV infection.¹ Patients also had to have cirrhotic status of Child-Pugh Class A or B only.¹

The study was conducted at six sites in the United States, located in Miami, Atlanta, Boston, Kansas City, New York, and Seattle, according to the registry.