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Completed

NCT Number: NCT02953301

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

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.

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Key information

Conditions

Mycosis Fungoides Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Sezary Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medizinische Universität Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

resminostat

Drug

Other names: 4SC-201

Placebo

Drug

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Other outcomes

  1. 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

  2. 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

  3. 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)

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

4SC AG

Industry

Registry information

Official study 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

Acronym: RESMAIN

Important dates

Study start
2016
Primary completion
2023
Study completion
2024
First posted
Nov 2, 2016
Registry last updated
Aug 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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