Date: 2014-09-02
Type of information: Recruitment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Celsion (USA - NJ)
Product: ThermoDox® (encapsulated doxorubicin) in combination with optimized radiofrequency ablation
Action mechanism:
Disease: hepatocellular carcinoma
Therapeutic area: Cancer - Oncology
Country: Canada, China, Germany, Hong Kong, Italy, Republic of Korea, Malaysia, Philippines, Spain, Taiwan, Thailand, USA
Trial
details: The Phase III OPTIMA Study is a global, pivotal, double-blind, placebo-controlled clinical trial that is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. The study is evaluating ThermoDox® in combination with optimized RFA, which will be standardized to a minimum of 45 minutes across all investigators and sites for treating lesions 3 to 7 centimeters, versus standardized RFA alone. The primary endpoint for the trial is Overall Survival. The statistical plan calls for two interim efficacy analyses by an independent Data Monitoring Committee (iDMC). (NCT02112656)
Latest
news: * On September 2, 2014, Celsion Corporation announced that the first patient has been enrolled in its pivotal Phase III OPTIMA Study of ThermoDox® in combination with optimized radiofrequency ablation (RFA) in patients with hepatocellular carcinoma. This Phase III study is expected to enroll 550 patients at up to 100 sites in the North America, Europe, China and Asia Pacific. As of June 30, 2014, data from the latest HEAT Study post-hoc analysis continued to strongly suggest that ThermoDox® may significantly improve Overall Survival compared to a RFA control in patients whose lesions undergo RFA treatment for 45 minutes or more. These findings apply to patients with single HCC lesions (64.4% of the HEAT Study population) from both size cohorts of the HEAT Study (3-5 cm and 5-7 cm) and represent a subgroup of 285 patients. For this group, clinical results indicate a 57% improvement in Overall Survival, a Hazard Ratio of 0.639 (95% CI 0.419 - 0.974), and a p-value of 0.037.
