CompletedPhase 2

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

Austria, Belgium, France201 participantsStarted 2016-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PFS (Progression-free survival)

Timeframe: 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

Trial details

NCT IDNCT02953301

Sponsor4SC AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-03

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