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

Sponsor
4SC AG (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02953301
Collaborator
(none)
201
54
2
89
3.7
0

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
201 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 1, 2016
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. PFS (Progression-free survival) [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.

    Secondary Outcome Measures

    1. TTSW (Time to symptom worsening): pruritus [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.

    Other Outcome Measures

    1. TTP (Time to progression) [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

    2. TTNT (Time to next treatment) [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

    3. PFS2, PFS3 (Progression-free survival 2, 3) [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)

    4. ORR (Overall response rate) [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

    5. DOR (Duration of response) [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

    6. OS (Overall survival) [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

    7. Incidence of treatment-related AEs and SAEs (Safety and tolerability) [Weekly for 3 cycles, then bi-weekly during treatment phase, up to approximately 9 months]

      Assess the safety and tolerability of resminostat

    8. HrQoL (Health related quality of life) [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

    9. Maximum Plasma Concentration [Cmax] [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

    10. Area Under the Curve [AUC] [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medizinische Universität Graz Graz Austria
    2 Medizinische Universität Wien Wien Austria
    3 Cliniques Universitaires Saint-Luc Bruxelles Belgium
    4 Universitaire Ziekenhuizen Leuven Belgium
    5 Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André Bordeaux France
    6 CHU Estaing Clermont-Ferrand France
    7 Centre Hospitalier Lyon-Sud Lyon France
    8 Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital Paris France
    9 Hopital Robert Debre - CHU de Reims Reims France
    10 Charité - Universitaetsmedizin Berlin Berlin Germany
    11 Universitaetsklinikum Bochum - St. Josef-Hospital Bochum Germany
    12 Elbekliniken Buxtehude Buxtehude Germany
    13 Uniklinik Köln Cologne Germany
    14 Klinikum Dortmund Dortmund Germany
    15 SRH Wald-Klinikum Gera Gera Germany
    16 Universitätsmedizin Göttingen Göttingen Germany
    17 Universitaetsklinikum Halle Halle (Saale) Germany
    18 Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany
    19 Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel Kiel Germany
    20 HELIOS Klinikum Krefeld Germany
    21 Klinikum der Stadt Ludwigshafen am Rhein Ludwigshafen am Rhein Germany
    22 Universitätsklinikum Schleswig-Holstein Lübeck Germany
    23 Universitätsklinikum Mannheim Mannheim Germany
    24 Johannes Wesling Klinikum Minden Minden Germany
    25 Universitäts-Hautklinik Tübingen Tübingen Germany
    26 Universitätsklinikum Ulm Ulm Germany
    27 ATTIKON Hospital and Cutaneous Lymphoma Clinic Athens Greece
    28 Universita Di Firenze Firenze Italy
    29 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano Italy
    30 Universita Cattolica del Sacro Cuore Roma Italy
    31 IFO San Gallicano Rome Italy
    32 Ospedale Molinette Turin Italy
    33 Niigata University Medical and Dental Hospital Niigata Japan
    34 Okayama University Hospital Okayama Japan
    35 Tohoku University Hospital Sendai Japan
    36 Hamamatsu University School of Medicine Shizuoka Japan
    37 University of Tsukuba Hospital Tsukuba Japan
    38 Leids Universitair Medisch Centrum (LUMC) Leiden Netherlands
    39 Medical University of Gdansk Gdansk Poland
    40 SP ZOZ Szpital Uniwersytecki w Krakowie Kraków Poland
    41 Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie Warsaw Poland
    42 Uniwersytecki Szpital Kliniczny im. WAM - CSW Łódź Poland
    43 Hospital Del Mar Barcelona Spain
    44 Hospital Duran i Reynals Barcelona Spain
    45 Hospital Universitario 12 de Octubre Madrid Spain
    46 Hospital Uni. Nuestra Senora de Candelaria Tenerife Spain
    47 Hospital General Universitario Valencia Spain
    48 Centre hospitalier universitaire vaudois (CHUV) Lausanne Switzerland
    49 Kantonsspital St. Gallen St. Gallen Switzerland
    50 Universitätsspital Zürich Zürich Switzerland
    51 University Hospital Birmingham United Kingdom
    52 Beatson West of Scotland Cancer Centre Glasgow United Kingdom
    53 St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust London United Kingdom
    54 Christie Hospital Manchester United Kingdom

    Sponsors and Collaborators

    • 4SC AG

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    4SC AG
    ClinicalTrials.gov Identifier:
    NCT02953301
    Other Study ID Numbers:
    • 4SC-201-6-2015
    • 2016-000807-99
    First Posted:
    Nov 2, 2016
    Last Update Posted:
    Jul 28, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by 4SC AG
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2022