CURRENT TRIALS

Delcath Systems Inc.

Overview of Phase II Trial:




STUDY DESIGN

o A phase II trial in Patients with unresectable cancers confined to the liver will receive treatments with Melphalan infused into the hepatic artery over 30 minutes via the Delcath System with filtration of the outflow from the hepatic vein through an extra-corporeal circuit
o Patients will be stratified for entry based on histology. This will include 4 cohorts of patients: neuroendocrine tumors, hepatocellular carcinoma, ocular or cutaneous melanoma, and metastatic adenocarcinoma.
o A maximum of 100-105 patients

OBJECTIVES OF THE STUDY

Primary Objective:

o To determine the response rate and duration of response to intra-hepatic infusion of melphalan with subsequent venous hemofiltration.
o This trial will be conducted using a four arm, Simon optimal phase II design for each arm. The arms will be: neuroendocrine tumors, adenocarcinoma, hepatocellular carcinoma, ocular and cutaneous melanoma (patients must have received prior regional melphalan therapy). For each arm, the objective will be to identify if a reasonably high 45% response probability (p1=0.45) may be identified as opposed to an undesirably low 20% probability (p0=0.20).

Secondary Objectives:

o To determine the patterns of recurrence in patients following this therapy.
o To determine the disease-free and overall survival in patients following this therapy.

ELIGIBILITY CRITERIA

o Male or female patients at least 16 years of age with a life expectancy of at least 3 months
o Histologically or cytologically proven cancer, predominantly in the parenchyma of the liver with one of the following histologies: adenocarcinoma, neuroendocrine tumor or primary hepatic malignancy. Patients with hepatic metastases from colorectal tumors are allowed if patients have been treated with first and second line chemotherapy including irenotecan and oxaliplatin.
o Patients must have an ECOG performance standard of < 3.
o Patients must have adequate hepatic function as evidence by a total serum bilirubin < 3.0 mg/dL and a PT within 2 seconds of the upper normal limit. AST/ALT must be ≤ 10 times upper limit of normal.

NCI TRIAL LISTING

> http://clinicaltrials.gov/ct/show/NCT00096083?order=3

For any questions, please contact
Delcath Systems, Inc.
Rockefeller Center
600 Fifth Avenue, 23rd Floor
New York, NY 10020
Telephone: (212) 489-2100
Fax: (212) 489-2102