Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS) (RESMAIN)
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| ClinicalTrials.gov Identifier: NCT02953301 |
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Recruitment Status :
Active, not recruiting
First Posted : November 2, 2016
Last Update Posted : September 6, 2023
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Sponsor:
4SC AG
Information provided by (Responsible Party):
4SC AG
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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 |
|---|---|---|
| Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell, Cutaneous | Drug: resminostat Drug: Placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| 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 : | November 2016 |
| Actual Primary Completion Date : | March 2023 |
| Estimated Study Completion Date : | June 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Fungal Infections
| Arm | Intervention/treatment |
|---|---|
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Experimental: resminostat
3 x 200 mg tablets p.o., 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
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Drug: resminostat
Other Name: 4SC-201 |
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Placebo Comparator: Placebo
3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity)
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Drug: Placebo |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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 Outcome Measures:
- 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
- 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
- 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)
- 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
- 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
- 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
- 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
- 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
- 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
- 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
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02953301
Locations
Show 54 study locations
Sponsors and Collaborators
4SC AG
Investigators
| Principal Investigator: | Rudolf Stadler, Prof. | Johannes Wesling Klinikum, Minden, Germany |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | 4SC AG |
| ClinicalTrials.gov Identifier: | NCT02953301 |
| Other Study ID Numbers: |
4SC-201-6-2015 2016-000807-99 ( EudraCT Number ) |
| First Posted: | November 2, 2016 Key Record Dates |
| Last Update Posted: | September 6, 2023 |
| Last Verified: | September 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by 4SC AG:
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Cutaneous T-Cell Lymphoma (CTLC) Maintenance resminostat 4SC |
HDAC Mycosis Fungoides Sézary Syndrome |
Additional relevant MeSH terms:
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Mycoses Mycosis Fungoides Sezary Syndrome Lymphoma, T-Cell Lymphoma, T-Cell, Cutaneous Syndrome Disease Pathologic Processes Lymphoma |
Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Bacterial Infections and Mycoses Infections Lymphoma, Non-Hodgkin |