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0 Diseases |  |
2 Trials |
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2 Trials |  |
11 News |  |
- | Melblez Kit (melphalan hepatic delivery system) / Delcath
Journal, Metastases: ASO Author Reflections: Optimizing Line of Therapy with the Melphalan/Hepatic Delivery System for Metastatic Uveal Melanoma. (Pubmed Central) - Aug 28, 2024
No abstract available
- ||| Melblez Kit (melphalan hepatic delivery system) / Delcath
P3 data, Journal, Metastases: ASO Visual Abstract: Efficacy and Safety of Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter, Phase 3 Study. (Pubmed Central) - May 25, 2024
No abstract available No abstract available
- ||| Melblez Kit (melphalan hepatic delivery system) / Delcath
P3 data, Journal, Metastases: Efficacy and Safety of the Melphalan/Hepatic Delivery System in Patients with Unresectable Metastatic Uveal Melanoma: Results from an Open-Label, Single-Arm, Multicenter Phase 3 Study. (Pubmed Central) - May 5, 2024
P3
Treatment with melphalan/HDS provides a clinically meaningful response rate and demonstrates a favorable benefit-risk profile in patients with unresectable mUM (study funded by Delcath; ClinicalTrials.gov identifier: NCT02678572; EudraCT no. 2015-000417-44).
- Melblez Kit (melphalan hepatic delivery system) / Delcath
Melphalan/hepatic delivery system versus best available care in patients with unresectable metastatic uveal melanoma: Randomized FOCUS trial results. (Hall A; Poster Bd #: 340) - Apr 24, 2024 - Abstract #ASCO2024ASCO_864;
P3
2015-000417-44). Treatment with melphalan/HDS shows clinically meaningful efficacy and demonstrates a favorable benefit-risk profile in patients with unresectable mUM as compared to best alternative care.
- || Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment open, Phase classification: An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma (clinicaltrials.gov) - Apr 5, 2023
P3, N=30, Recruiting, Sponsor: Delcath Systems Inc.
Treatment with melphalan/HDS shows clinically meaningful efficacy and demonstrates a favorable benefit-risk profile in patients with unresectable mUM as compared to best alternative care. Available --> Recruiting | Phase classification: PN/A --> P3
- ||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial primary completion date: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Mar 7, 2023
P3, N=102, Active, not recruiting, Sponsor: Delcath Systems Inc.
Available --> Recruiting | Phase classification: PN/A --> P3 Trial primary completion date: Jun 2022 --> Dec 2022
- || Melblez Kit (melphalan hepatic delivery system) / Delcath
NDA: $DCTH resubmits NDA for HEPZATO kit (Twitter) - Feb 13, 2023
- ||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial termination: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma (clinicaltrials.gov) - Oct 17, 2022
P2, N=17, Terminated, Sponsor: Delcath Systems Inc.
Trial primary completion date: Jun 2022 --> Dec 2022 Suspended --> Terminated; Limited enrollment
- ||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial completion date, Trial primary completion date: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Mar 24, 2022
P3, N=102, Active, not recruiting, Sponsor: Delcath Systems Inc.
Suspended --> Terminated; Limited enrollment Trial completion date: Jul 2021 --> May 2023 | Trial primary completion date: May 2021 --> Jun 2022
- || Melblez Kit (melphalan hepatic delivery system) / Delcath
Review, Journal: A New Option for the Treatment of Intrahepatic Cholangiocarcinoma: Percutaneous Hepatic Perfusion with CHEMOSAT Delivery System. (Pubmed Central) - Aug 26, 2021
We reviewed available loco-regional therapeutic options, with particular focus on the CHEMOSAT Melphalan/Hepatic Delivery System (CS-HDS), which is uniquely positioned to perform a percutaneous hepatic perfusion (PHP), in order to treat the entire liver as a standalone or as complementary therapy...More than 650 procedures have been performed in Europe to date, mostly to treat liver metastases from UM. In CCA, experience is still limited, but retrospective analyses have been reported, while phase II and III studies are closed, waiting for results or ongoing.
- |||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
New trial: An Open-Label Expanded Access Study of the Melphalan/Hepatic Delivery System (HDS) in Patients With Hepatic Dominant Ocular Melanoma (clinicaltrials.gov) - Aug 25, 2021
P, N=0, Available, Sponsor: Delcath Systems Inc.
In CCA, experience is still limited, but retrospective analyses have been reported, while phase II and III studies are closed, waiting for results or ongoing. .
- ||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment closed: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Mar 10, 2021
P2/3, N=295, Active, not recruiting, Sponsor: Delcath Systems Inc.
. Recruiting --> Active, not recruiting
- |||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment closed, Trial completion date, Trial primary completion date: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Sep 28, 2020
P3, N=102, Active, not recruiting, Sponsor: Delcath Systems Inc.
Recruiting --> Active, not recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jul 2021 | Trial primary completion date: Apr 2020 --> May 2021
- | Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Sep 7, 2018
P3, N=80, Recruiting, Sponsor: Delcath Systems Inc.
Recruiting --> Active, not recruiting | Trial completion date: Jun 2020 --> Jul 2021 | Trial primary completion date: Apr 2020 --> May 2021 N=240 --> 80 | Trial completion date: Jun 2019 --> Jun 2020 | Initiation date: Jan 2015 --> Feb 2016 | Trial primary completion date: Jun 2019 --> Apr 2020
- Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment change, Trial suspension, Trial primary completion date: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma (clinicaltrials.gov) - Jan 31, 2018
P2, N=17, Suspended, Sponsor: Delcath Systems Inc.
N=240 --> 80 | Trial completion date: Jun 2019 --> Jun 2020 | Initiation date: Jan 2015 --> Feb 2016 | Trial primary completion date: Jun 2019 --> Apr 2020 N=42 --> 17 | Recruiting --> Suspended | Trial primary completion date: Dec 2017 --> Mar 2018
- ||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial initiation date: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jan 31, 2018
P2/3, N=295, Not yet recruiting, Sponsor: Delcath Systems Inc.
N=42 --> 17 | Recruiting --> Suspended | Trial primary completion date: Dec 2017 --> Mar 2018 Initiation date: Dec 2017 --> Mar 2018
- Melblez Kit (melphalan hepatic delivery system) / Delcath
New P2 trial: Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC (clinicaltrials.gov) - Dec 19, 2017
P2, N=0, Withdrawn, Sponsor: Delcath Systems Inc.
- Melblez Kit (melphalan hepatic delivery system) / Delcath
Enrollment change, Trial withdrawal, Trial primary completion date: Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC (clinicaltrials.gov) - Dec 18, 2017
P2, N=0, Withdrawn, Sponsor: Delcath Systems Inc.
Initiation date: Dec 2017 --> Mar 2018 N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017 | N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017 | N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017
- Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial primary completion date: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma (clinicaltrials.gov) - Jul 26, 2017
P2, N=42, Recruiting, Sponsor: Delcath Systems Inc.
N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017 | N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017 | N=31 --> 0 | Recruiting --> Withdrawn | Trial primary completion date: Aug 2017 --> Dec 2017 Trial primary completion date: Jun 2016 --> Dec 2017
- Melblez Kit (melphalan hepatic delivery system) / Delcath
Clinical: Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC (clinicaltrials.gov) - Jul 26, 2017
P2, N=31, Recruiting, Sponsor: Delcath Systems Inc.
Trial primary completion date: Jun 2016 --> Dec 2017 Trial primary completion date: Jun 2016 --> Aug 2017
- ||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
Trial initiation date: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Jul 25, 2017
P2/3, N=295, Not yet recruiting, Sponsor: Delcath Systems Inc.
Trial primary completion date: Jun 2016 --> Aug 2017 Initiation date: Sep 2017 --> Dec 2017
- |||||||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
New P2/3 trial: Percutaneous Hepatic Perfusion vs. Cisplatin/Gemcitabine in Patients With Intrahepatic Cholangiocarcinoma (clinicaltrials.gov) - Mar 22, 2017
P2/3, N=295, Not yet recruiting, Sponsor: Delcath Systems Inc.
- |||||||||| Melblez Kit (melphalan hepatic delivery system) / Delcath
New P3 trial: FOCUS: Percutaneous Hepatic Perfusion in Patients With Hepatic-dominant Ocular Melanoma (clinicaltrials.gov) - Feb 10, 2016
P3, N=240, Recruiting, Sponsor: Delcath Systems Inc.
- | Melblez Kit (melphalan hepatic delivery system) / Delcath
New P2 trial: Melphalan for Use With the Hepatic Delivery System Treatment in Patients With Unresectable Hepatocellular Carcinoma or Intra Hepatic Cholangiocarcinoma (clinicaltrials.gov) - Apr 14, 2015
P2, N=42, Recruiting, Sponsor: Delcath Systems Inc.
- | Melblez Kit (melphalan hepatic delivery system) / Delcath
Clinical: Sequential Melphalan for Use With Hepatic Delivery System Treatment Followed by Sorafenib in Patients With Unresectable HCC (clinicaltrials.gov) - Apr 2, 2015
P2, N=31, Recruiting, Sponsor: Delcath Systems Inc.