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Last Updated: March 28, 2024

CLINICAL TRIALS PROFILE FOR RESMINOSTAT


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Clinical Trials for Resminostat

Trial ID Title Status Sponsor Phase Summary
NCT00943449 ↗ 4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma Completed 4SC AG Phase 2 The purpose of the study is to determine whether 4SC-201 alone or in combination with Sorafenib is effective and safe in the treatment of hepatocellular carcinoma in patients refractory to Sorafenib monotherapy.
NCT01037478 ↗ Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma Completed 4SC AG Phase 2 The purpose of this study is to determine whether Resminostat (4SC-201) is effective and safe in the treatment of relapsed or refractory Hodgkin's Lymphoma.
NCT01277406 ↗ 4SC-201 (Resminostat) in Advanced Colorectal Carcinoma Completed 4SC AG Phase 1/Phase 2 The purpose of this study is to determine the Maximum Tolerated Dose (MTD) of 4SC-201 (Resminostat) in combination with FOLFIRI and whether 4SC-201 (Resminostat) is effective and safe in combination FOLFIRI versus FOLFIRI alone in the treatment of advanced colorectal carcinoma.
NCT02400788 ↗ Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC) Completed Yakult Honsha Co., LTD Phase 1/Phase 2 The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.
NCT02953301 ↗ Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) Recruiting 4SC AG Phase 2 The purpose of this study is to determine whether resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have recently achieved disease control with previous systemic therapy.
NCT04955340 ↗ A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat Not yet recruiting 4SC AG Phase 1 Resminostat is a potent, orally available inhibitor of Class I, IIb and IV histone deacetylases (HDACs), including a pronounced activity against HDAC6. Resminostat targets epigenetic changes observed in tumour cells and has the potential to provide significant benefit to patients with advanced malignancies by inhibiting tumour progression and metastasis or even inducing tumour regression. This will be a Phase 1, open-label, non-randomized, single dose study of the absorption, metabolism, excretion of [14C] resminostat following a single oral dose in healthy male participants. The purpose of this study is to determine the absorption, metabolism, and excretion (AME) of [14C] resminostat and to characterize and determine the metabolites present in plasma, urine, and, where possible, faeces in healthy male participants following a single oral administration. Knowledge of the metabolism and excretion of parent drug and its metabolites is useful for evaluating the Metabolites in Safety Testing requirements elucidated in the International Conference on Harmonisation (ICH) M3, and the likelihood of effects of renal or hepatic impairment on the disposition of resminostat, and the likelihood for drug-drug interactions with resminostat. The results from this study may guide future study designs using special populations or evaluating the potential for drug-drug interactions.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Resminostat

Condition Name

Condition Name for
Intervention Trials
Hepatocellular Carcinoma 2
Mycosis Fungoides 2
Sezary Syndrome 2
Advanced Colorectal Carcinoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Carcinoma 3
Mycosis Fungoides 2
Carcinoma, Hepatocellular 2
Mycoses 2
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Clinical Trial Locations for Resminostat

Trials by Country

Trials by Country for
Location Trials
Germany 3
Poland 2
Japan 2
United Kingdom 2
Italy 2
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Clinical Trial Progress for Resminostat

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 2 3
Phase 1/Phase 2 2
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 4
Recruiting 1
Not yet recruiting 1
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Clinical Trial Sponsors for Resminostat

Sponsor Name

Sponsor Name for
Sponsor Trials
4SC AG 5
Yakult Honsha Co., LTD 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 6
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