Trial | NCT02953301  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Intervention/Treatment

    resminostat ...

  • Study Participants

    201
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 Started
Nov 30
2016
Primary Completion
Mar 31
2023
Study Completion
Jun 30
2024
Anticipated
Last Update
Sep 06
2023

Drug resminostat

  • Other names: 4SC-201

Drug Placebo

resminostat Experimental

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

Placebo Placebo Comparator

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

Criteria 

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
No Results Posted