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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: 4SC AG

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome: 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.


Original Secondary Outcome: Same as current

Information By: 4SC AG

Dates:
Date Received: October 26, 2016
Date Started: November 2016
Date Completion: February 2020
Last Updated: May 12, 2017
Last Verified: May 2017