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Delcath Systems (DCTH)
NASDAQ:DCTH
Melphalan/Hds Followed By Physician's Choice Of Soc (Eribulin, Vinorelbine, Or Capecitabine), Physician's Choice Of Soc (Eribulin, Vinorelbine, Or Capecitabine)
Metastatic Breast Cancer In The Liver
Phase II
Not Yet 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
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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
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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 (DCTH) have in its pipeline
DCTH is currently developing the following drugs: Melphalan/Hds Followed By Physician's Choice Of Soc (Eribulin, Vinorelbine, Or Capecitabine), Physician's Choice Of Soc (Eribulin, Vinorelbine, Or Capecitabine), Melphalan/Hds Followed By Consolidation Treatment With Trifluridine-Tipiracil Plus Bevacizumab, Trifluridine-Tipiracil Plus Bevacizumab Alone. These drug candidates are in various stages of clinical development as the company works toward FDA approval.