On February 10, 2016 Delcath Systems, Inc. (NASDAQ: DCTH), a specialty pharmaceutical and medical device company focused on oncology with an emphasis on the treatment of primary and metastatic liver cancers, reported that patient enrollment has begun in the Company’s Phase 3 clinical trial: "A Randomized, Controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Melphalan/HDS Treatment in Patients with Hepatic-Dominant Ocular Melanoma" (the FOCUS Trial) (Press release, Delcath Systems, FEB 10, 2016, View Source;p=RssLanding&cat=news&id=2137162 [SID:1234509027]). The first patient was evaluated and randomized into the trial at the Moffitt Cancer Center in Tampa, Florida.
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The FOCUS Trial is evaluating the efficacy, safety and pharmacokinetics of Melphalan/HDS versus best alternative care in 240 patients with ocular melanoma (OM). The primary objective of the study is a comparison of overall survival between the Melphalan/HDS treatment arm and best alternative care comprised of selected therapies; secondary objectives include overall progression-free survival and objective response rate, each as determined by the Investigator, while exploratory objectives include progression-free survival, objective response rate, hepatic progression free survival and hepatic objective response rate all as determined by Independent Central Review, and quality of life measures. The FOCUS Trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA) to support marketing approval in the U.S.
"Our team at Moffitt Cancer Center is very excited to begin this trial and is looking forward to verifying the potential for Melphalan/HDS in this life-threatening cancer with no effective treatment options," said Jonathan Zager, M.D., FACS, Professor of Surgery in the Cutaneous Oncology and Sarcoma Departments and a Senior Member at Moffitt Cancer Center, and the FOCUS Trial’s principal investigator.
"Given the high unmet medical need in hepatic dominant ocular melanoma, it is not surprising to see enrollment in our FOCUS Trial begin quickly," said Jennifer K. Simpson, Ph.D., MSN, CRNP, President and CEO of Delcath. "Interest in the FOCUS Trial has been strong among other major cancer centers, and we expect to announce additional trial sites globally in the near term."