Melphalan/Hds Followed By Physician's Choice Of Soc, Physician's Choice Of Soc
Metastatic Breast Cancer In The Liver
Phase II
Recruiting
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
Mar 06, 2025
Melphalan/Hds Followed By Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab, Trifluridine-Tipiracil Plus Bevacizumab Alone
Refractory Metastatic Colorectal Cancer
Phase II
Recruiting
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
Sep 14, 2024
Melphalan With Hepatic Delivery System, Hepzato
Metastatic Uveal Melanoma, Metastatic Ocular Melanoma
Phase III
Unknown
An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma
Aug 18, 2021
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Melphalan/Hds
Uveal Melanoma, Ocular Melanoma
Phase III
Completed
Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma
Feb 01, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Delcath Systems (DV3R) have in its pipeline
DV3R is currently developing the following drugs: Melphalan/Hds Followed By Physician's Choice Of Soc, Physician's Choice Of Soc, Melphalan/Hds Followed By Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab, Trifluridine-Tipiracil Plus Bevacizumab Alone, Melphalan With Hepatic Delivery System, Hepzato. These drug candidates are in various stages of clinical development as the company works toward FDA approval.