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

September 4, 2023 updated by: 4SC AG

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

201

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
        • Medizinische Universität Graz
      • Wien, Austria
        • Medizinische Universität Wien
  • Belgium
      • Bruxelles, Belgium
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium
        • Universitaire Ziekenhuizen
  • France
      • Bordeaux, France
        • Centre Hospitalier Universitaire (CHU) de Bordeaux - Hopital Saint-Andre
      • Clermont-Ferrand, France
        • CHU Estaing
      • Lyon, France
        • Centre hospitalier Lyon-Sud
      • Paris, France
        • Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital
      • Reims, France
        • Hôpital Robert Debré - CHU de Reims
  • Germany
      • Berlin, Germany
        • Charite - Universitaetsmedizin Berlin
      • Bochum, Germany
        • Universitaetsklinikum Bochum - St. Josef-Hospital
      • Buxtehude, Germany
        • Elbekliniken Buxtehude
      • Cologne, Germany
        • Uniklinik Köln
      • Dortmund, Germany
        • Klinikum Dortmund
      • Gera, Germany
        • SRH Wald-Klinikum Gera
      • Göttingen, Germany
        • Universitatsmedizin Gottingen
      • Halle (Saale), Germany
        • Universitaetsklinikum Halle
      • Hamburg, Germany
        • Universitaetsklinikum Hamburg-Eppendorf
      • Kiel, Germany
        • Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel
      • Krefeld, Germany
        • Helios Klinikum
      • Ludwigshafen am Rhein, Germany
        • Klinikum der Stadt Ludwigshafen am Rhein
      • Lübeck, Germany
        • Universitatsklinikum Schleswig-Holstein
      • Mannheim, Germany
        • Universitätsklinikum Mannheim
      • Minden, Germany
        • Johannes Wesling Klinikum Minden
      • Tübingen, Germany
        • Universitäts-Hautklinik Tübingen
      • Ulm, Germany
        • Universitatsklinikum Ulm
  • Greece
      • Athens, Greece
        • ATTIKON Hospital and Cutaneous Lymphoma Clinic
  • Italy
      • Firenze, Italy
        • Universita Di Firenze
      • Milano, Italy
        • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico
      • Roma, Italy
        • Universita Cattolica del Sacro Cuore
      • Rome, Italy
        • IFO San Gallicano
      • Turin, Italy
        • Ospedale Molinette
  • Japan
      • Niigata, Japan
        • Niigata University Medical And Dental Hospital
      • Okayama, Japan
        • Okayama University Hospital
      • Sendai, Japan
        • Tohoku University Hospital
      • Shizuoka, Japan
        • Hamamatsu University School of Medicine
      • Tsukuba, Japan
        • University of Tsukuba Hospital
  • Netherlands
      • Leiden, Netherlands
        • Leids Universitair Medisch Centrum (LUMC)
  • Poland
      • Gdansk, Poland
        • Medical University of Gdansk
      • Kraków, Poland
        • Sp Zoz Szpital Uniwersytecki W Krakowie
      • Warsaw, Poland
        • Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie
      • Łódź, Poland
        • Uniwersytecki Szpital Kliniczny im. WAM - CSW
  • Spain
      • Barcelona, Spain
        • Hospital del Mar
      • Barcelona, Spain
        • Hospital Duran I Reynals
      • Madrid, Spain
        • Hospital Universitario 12 de octubre
      • Tenerife, Spain
        • Hospital Uni. Nuestra Senora de Candelaria
      • Valencia, Spain
        • Hospital General Universitario
  • Switzerland
      • Lausanne, Switzerland
        • Centre Hospitalier Universitaire Vaudois (Chuv)
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen
      • Zürich, Switzerland
        • Universitatsspital Zurich
  • United Kingdom
      • Birmingham, United Kingdom
        • University Hospital
      • Glasgow, United Kingdom
        • Beatson West of Scotland Cancer Centre
      • London, United Kingdom
        • St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust
      • Manchester, United Kingdom
        • Christie Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Main Inclusion Criteria:

  • Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing complete response (CR), partial response (PR) or stable disease (SD) after at least one prior systemic therapy according to local standards (including but not limited to α-interferon, bexarotene, total skin electron beam irradiation, chemotherapy) [the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-12 weeks prior to randomisation]
  • Eastern Cooperative Oncology Group (ECOG) status score 0-2
  • Adequate haematological, hepatic and renal function

Main Exclusion Criteria:

  • Patients with progressive disease (PD)
  • Baseline corrected QT (QTc) interval > 500 milliseconds
  • Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resminostat
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: resminostat
Other Names:
  • 4SC-201
Placebo Comparator: Placebo
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS (Progression-free survival)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 32 months
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.
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to approximately 32 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTSW (Time to symptom worsening): pruritus
Time Frame: From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale
To determine if maintenance treatment with resminostat increases time to symptom (pruritus) worsening (TTSW) compared to placebo.
From date of randomisation to first date that criteria for symptom (pruritus) worsening have been met, up to approximately 32 months. Symptom worsening is defined as an increase of a minimum of 3 points on the visual analogue itching scale

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
TTP (Time to progression)
Time Frame: From date of randomization until the date of first documented progression, up to approximately 32 months
Compare time to progression (TTP) in patients when treated with resminostat vs placebo
From date of randomization until the date of first documented progression, up to approximately 32 months
TTNT (Time to next treatment)
Time Frame: From date of randomisation to first date that new treatment is received, up to approximately 44 months.
Compare time to next treatment (TTNT) in patients when treated with resminostat vs placebo
From date of randomisation to first date that new treatment is received, up to approximately 44 months.
PFS2, PFS3 (Progression-free survival 2, 3)
Time Frame: From date of start of subsequent treatment to date of progression or death due to any cause in the absence of documented PD whilst receiving second and third line therapy, respectively, up to approximately 44 months
Assess the effect of maintenance treatment with resminostat by means of PFS of subsequent treatments (PFS2, PFS3)
From date of start of subsequent treatment to date of progression or death due to any cause in the absence of documented PD whilst receiving second and third line therapy, respectively, up to approximately 44 months
ORR (Overall response rate)
Time Frame: Percent of patients within each treatment Arm that achieve confirmed CR or PR relative to the number of patients belonging to the analysis population of interest, up to approximately 32 months.
Compare overall response rate (ORR, including CR, PR) in patients when treated with resminostat vs placebo
Percent of patients within each treatment Arm that achieve confirmed CR or PR relative to the number of patients belonging to the analysis population of interest, up to approximately 32 months.
DOR (Duration of response)
Time Frame: From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
Compare duration of response (DOR) in patients when treated with resminostat vs placebo
From date confirmed CR or PR (whichever is first) until the criteria for PD have been met, up to approximately 32 months.
OS (Overall survival)
Time Frame: From the day of randomisation to death from any cause, up to approximately 44 months.
Compare overall survival (OS) in patients when treated with resminostat vs placebo
From the day of randomisation to death from any cause, up to approximately 44 months.
Incidence of treatment-related AEs and SAEs (Safety and tolerability)
Time Frame: Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
Assess the safety and tolerability of resminostat
Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months
HrQoL (Health related quality of life)
Time Frame: Every 28 days, up to approximately 32 months
Compare changes in health related quality of life (HrQoL) parameters in patients when treated with resminostat vs placebo
Every 28 days, up to approximately 32 months
Maximum Plasma Concentration [Cmax]
Time Frame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Assess the maximum plasma concentration [Cmax] of resminostat and metabolites
At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Area Under the Curve [AUC]
Time Frame: At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication
Assess the Area Under the Curve [AUC] of resminostat and metabolites
At Cycle 3, Day 1 at 0.75h, 2h and 4 h after intake of trial medication / at Cycle 3, Day 5 to be done pre-dose and at 2h and 7h after intake of trial medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

4SC AG

Investigators

  • Principal Investigator: Rudolf Stadler, Prof., Johannes Wesling Klinikum, Minden, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

October 26, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimated)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 4, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4SC-201-6-2015
  • 2016-000807-99 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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