Delcath Systems has commenced the Phase III trial of Melphalan Hydrochloride for Injection for use with the Delcath Hepatic Delivery System (Melphalan/HDS) to treat patients with hepatic dominant ocular melanoma (OM).
The Focus clinical trial will assess the safety, efficacy and pharmacokinetic profile of Melphalan/HDS against best alternative care in 240 patients with OM.
Under a special protocol assessment (SPA) with the US Food and Drug Administration (FDA), the trial is being carried out at various cancer centers in the US and Europe.
The company has started the trial at the Moffitt Cancer Center at Tampa in Florida, US, under the guidance of Moffitt senior member and principal investigator Dr Jonathan Zager.
Delcath Systems president and CEO Dr Jennifer Simpson said: "We are delighted to be working with the Moffitt Cancer Center and look forward to activating a number of other premier cancer centers as clinical sites in the coming months."
According to the firm, the primary endpoint is a comparison of overall survival between the two study arms, while secondary and exploratory endpoints comprise of progression-free survival, overall response rate and quality of life measures.
In the treatment phase of the study, patients randomized to the Melphalan/HDS arm will receive up to six treatments at intervals of six to eight weeks for up to one year.
The company will evaluate tumor response in both study arms every 12 weeks until evidence of hepatic disease progression.
Disease assessment scans will continue every 12 weeks for up to two years for patients progressing to the follow-up phase.