Clinical Trial: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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 Unresectabl
Brief 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 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 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.
Sponsor: Delcath Systems Inc.
Current Primary Outcome: Objective response rate in percentage of Melphalan/HDS treatment [ Time Frame: 2 years ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of patients with adverse events after treatment with Melphalan/HDS. [ Time Frame: 2 years ]
- Progression free survival in months of patients receiving Melphalan/HDS treatment. [ Time Frame: 2 years ]
Original Secondary Outcome: Same as current
Information By: Delcath Systems Inc.
Dates:
Date Received: April 8, 2015
Date Started: June 2014
Date Completion: August 2016
Last Updated: April 13, 2015
Last Verified: April 2015
