Phase 2 Clinical Trials in Hepatocellular Carcinoma (HCC) and Intrahepatic Cholangiocarcinoma (ICC)

Protocol PHP-HCC-201 – (NCT 02406508)

Currently open in the U.S., this trial in patients with HCC will assess the safety and efficacy of Melphalan/HDS followed by sorafenib. The trial will evaluate overall response rate via modified Response Evaluation Criteria in Solid Tumors (mRECIST), progression free survival, characterize the systemic exposure of melphalan and assess patient quality of life. Centers open are The Moffitt Cancer Center in Tampa, Florida and Montefiore Medical Center in New York City.

Protocol PHP-HCC-202 – (NCT 02415036)

Currently open in Europe, this trial in patients with HCC and ICC will assess the safety and efficacy of Melphalan/HDS. The trial will also evaluate overall response rate via (mRECIST) criteria, progression free survival, characterize the systemic exposure of melphalan and assess patient quality of life. Three hospitals in Germany have opened for enrollment --- Goethe University Hospital, Hannover Medical School Hospital and Jena University Hospital. Additional centers in Germany, the U.K. and Italy are in the process of being opened subject to the applicable authorizations and approvals including ethics committee approval at participating hospitals.


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