COMPANY
Delcath
Timeline
- Trial start Phase 2: Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in source ↗
- Trial start Phase 2: Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in source ↗
- Trial start Phase 3: An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma source ↗
- Trial start Phase 2/Phase 3: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma source ↗
- Trial start Phase 3: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma source ↗
- Trial start —: Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy source ↗
- Trial start Phase 2: Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC source ↗
- Trial start Phase 2: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma source ↗
- Trial start Phase 3: Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma source ↗
- Trial start Phase 2: Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer source ↗
Upcoming milestones
- 2026-12 (ESTIMATED) · Phase 2 · Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients · NCT06607458
- 2029-05 (ESTIMATED) · Phase 2 · Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients · NCT06875128
Clinical trials (lead sponsor) 11
| Record | Title | Phase | Status | Start | Primary completion |
|---|---|---|---|---|---|
| NCT02678572 | Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma | Phase 3 | Completed | Feb 1, 2016 | May 18, 2023 (actual) |
| NCT06607458 | Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Colorectal Cancer w/Liver Dominant Disease | Phase 2 | Recruiting | Aug 5, 2025 | 2026-12 (estimated) |
| NCT06875128 | Evaluation of the Safety and Efficacy of Treatment w/High Dose Melphalan Given Directly Into the Liver Followed by Treatment w/Approved Cancer Treatment or Approved Cancer Treatment Alone in Patients w/ Metastatic Breast Cancer w/Liver Dominant Disease | Phase 2 | Recruiting | Jan 29, 2026 | 2029-05 (estimated) |
| NCT05022901 | An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma | Phase 3 | Active, not recruiting | Jun 10, 2022 | Mar 1, 2024 (estimated) |
| NCT02415036 | Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma | Phase 2 | Terminated | 2014-06 | 2018-10 (actual) |
| NCT03086993 | Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma | Phase 2/Phase 3 | Unknown status (ClinicalTrials.gov) | Apr 10, 2018 | 2023-01 (estimated) |
| NCT00324727 | Hepatic Arterial Infusion With Melphalan Compared With Standard Therapy in Treating Patients With Unresectable Liver Metastases Due to Melanoma | Phase 3 | Completed | 2006-02 | 2012-08 (actual) |
| NCT03266042 | Registry Protocol- Melphalan Percutaneous Hepatic Perfusion for the Treatment of Unresectable Hepatic Malignancy | Not listed | Unknown status (ClinicalTrials.gov) | Jan 14, 2016 | 2020-01 (estimated) |
| NCT02406508 | Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC | Phase 2 | Withdrawn | 2014-10 | 2017-12 (actual) |
| NCT01728051 | Expanded Access Study of Melphalan With Delcath CS-PHP System in Patients With Ocular/Cutaneous Melanoma Mets to Liver | Not listed | No longer available | Not listed | Not listed |
| NCT00096083 | Hepatic Arterial Infusion of Melphalan With Hepatic Perfusion in Treating Patients With Unresectable Liver Cancer | Phase 2 | Completed | 2004-09 | 2012-08 (actual) |