NCT02415036

Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma

An International Multi-center Phase 2 Study to Evaluate the Efficacy and Safety of Melphalan Hydrochloride for Injection for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Delcath Systems Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and safety of Melphalan/HDS in patients with unresectable Hepatocellular Carcinoma (HCC) or Intra Hepatic Cholangiocarcinoma (ICC) confined to the liver.

Detailed description

This is a two arm, open label, multi-center, Phase 2 study to evaluate the efficacy and safety of Melphalan/HDS in patients with unresectable HCC or ICC confined to the liver. Eligible patients will receive up to 2 Melphalan/HDS treatments. Each treatment cycle consists of 6 weeks with an acceptable delay for another 2 weeks before next planned treatment. Tumor response will be assessed at the end of cycle 2. The Melphalan/HDS treatment will be terminated in patients with progressive disease (PD) after the 1st treatment and based on safety in patients with \> 8 weeks delay of recovery from toxicity.

Conditions

• Hepatocellular Carcinoma
• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
DEVICE	Delcath Hepatic Delivery System
DRUG	Melphalan

Timeline

• Start date: 2014-06-01
• Primary completion: 2018-10-01
• Completion: 2018-12-01
• First posted: 2015-04-14
• Last updated: 2022-10-17

Locations

3 sites across 1 country: Germany