Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Infections

Rare Diseases

Syndrome

Lymphoma

Lymphoma, T-Cell

Lymphoma, T-Cell, Peripheral

Mycoses

Mycosis Fungoides

Lymphoma, T-Cell, Cutaneous

Sezary Syndrome

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Communicable Diseases

Bacterial Infections

Bacterial Infections and Mycoses

Lymphoma, Non-Hodgkin

Lymphosarcoma

Peripheral T-cell Lymphoma

Cutaneous T-cell Lymphoma

3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)

3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)

resminostat

Placebo

Rudolf Stadler, Prof.

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.

Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)

A Multicentre, Double Blind, Randomised, Placebo-controlled, Phase II Trial to Evaluate Resminostat for Maintenance Treatment of Patients With Advanced Stage (Stage IIB-IVB) Mycosis Fungoides (MF) or Sézary Syndrome (SS) That Have Achieved Disease Control With Systemic Therapy - the RESMAIN Study

Compare time to progression (TTP) in patients when treated with resminostat vs placebo

Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo

Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)

Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo

Compare duration of response (DOR) in patients when treated with resminostat vs placebo

Compare overall survival (OS) in patients when treated with resminostat vs placebo

Assess the safety and tolerability of resminostat

Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo

Assess the maximum plasma concentration \[Cmax\] of resminostat and metabolites

Assess the Area Under the Curve \[AUC\] of resminostat and metabolites

The primary objective is to determine if maintenance treatment with resminostat increases progression free survival (PFS) compared to placebo in patients with advanced stage (Stage IIB-IVB) MF or SS that have achieved disease control (complete response \[CR\], partial response \[PR\] or stable disease \[SD\]) with previous systemic therapy.

To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.

4SC AG

Digestive System Diseases

Carcinoma

Colorectal Neoplasms

Neoplasms, Glandular and Epithelial

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

4SC-201(Resminostat)

FOLFIRI

Dirk Jäger, Prof. Dr.

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.

4SC-201 (Resminostat) in Advanced Colorectal Carcinoma

A Phase I/II Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Resminostat (4SC-201) in Combination With a Second-line Treatment in Patients With K-ras Mutated Advanced Colorectal Carcinoma

Hodgkin Disease

Hodgkin Lymphoma

All Drugs and Chemicals

Histone Deacetylase Inhibitors

Resminostat (4SC-201)

Jan Walewski, Prof.

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.

Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma

A Phase 2 Proof of Concept Study to Evaluate the Efficacy, Safety and Pharmacokinetics of the HDAC Inhibitor 4SC-201 in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Carcinoma, Hepatocellular

Disease Progression

Adenocarcinoma

Liver Neoplasms

Liver Diseases

Antineoplastic Agents

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

4SC-201

Michael Bitzer, Prof. MD

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.

4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma

A Proof-of-concept Phase II Study to Evaluate Efficacy, Safety and Pharmacokinetics of 4SC-201 and the Treatment Combination of Sorafenib Plus 4SC-201 in Patients With Hepatocellular Carcinoma Exhibiting Progressive Disease Under Sorafenib Treatment

Resminostat

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.

Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)

A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG
4SC-201 (Resminostat) in Advanced Colorectal Carcinoma	NCT01277406	Advanced Colore...	4SC-201(Resmino... FOLFIRI	18 Years -	4SC AG
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG
Resminostat (4SC-201) in Relapsed or Refractory Hodgkin's Lymphoma	NCT01037478	Hodgkin's Lymph...	Resminostat (4S...	18 Years -	4SC AG
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)	NCT02953301	Mycosis Fungoid... Sezary Syndrome Lymphoma, T-Cel...	resminostat Placebo	18 Years -	4SC AG
4SC-201 (Resminostat) in Advanced Colorectal Carcinoma	NCT01277406	Advanced Colore...	4SC-201(Resmino... FOLFIRI	18 Years -	4SC AG
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma	NCT00943449	Hepatocellular ...	4SC-201 Sorafenib	18 Years -	4SC AG
Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)	NCT02400788	Hepatocellular ...	Resminostat Sorafenib	20 Years -	Yakult Honsha Co., LTD
4SC-201 (Resminostat) and Sorafenib in Advanced Hepatocellular Carcinoma	NCT00943449	Hepatocellular ...	4SC-201 Sorafenib	18 Years -	4SC AG

Spots Global Cancer Trial Database for resminostat

Every month we try and update this database with for resminostat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for resminostat

Every month we try and update this database with for resminostat cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for resminostat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.