RESMAIN: Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
Study Details
Study Description
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 |
---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
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) |
Drug: resminostat
Other Names:
|
Placebo Comparator: Placebo 3 tablets p.o. matching verum, 5 days treatment followed by 9 days rest (cycles until progress or unacceptable toxicity) |
Drug: Placebo
|
Outcome Measures
Primary Outcome Measures
- PFS (Progression-free survival) [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 [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) [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) [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) [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) [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) [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) [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) [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) [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] [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] [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
Eligibility Criteria
Criteria
Main Inclusion Criteria:
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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]
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Eastern Cooperative Oncology Group (ECOG) status score 0-2
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Adequate haematological, hepatic and renal function
Main Exclusion Criteria:
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Patients with progressive disease (PD)
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Baseline corrected QT (QTc) interval > 500 milliseconds
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Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, radiation therapy, or experimental medications
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medizinische Universität Graz | Graz | Austria | ||
2 | Medizinische Universität Wien | Wien | Austria | ||
3 | Cliniques Universitaires Saint-Luc | Bruxelles | Belgium | ||
4 | Universitaire Ziekenhuizen | Leuven | Belgium | ||
5 | Centre Hospitalier Universitaire (CHU) de Bordeaux - Hôpital Saint-André | Bordeaux | France | ||
6 | CHU Estaing | Clermont-Ferrand | France | ||
7 | Centre Hospitalier Lyon-Sud | Lyon | France | ||
8 | Chu Paris-Gh St-Louis Lariboisiere F.Widal Hopital | Paris | France | ||
9 | Hopital Robert Debre - CHU de Reims | Reims | France | ||
10 | Charité - Universitaetsmedizin Berlin | Berlin | Germany | ||
11 | Universitaetsklinikum Bochum - St. Josef-Hospital | Bochum | Germany | ||
12 | Elbekliniken Buxtehude | Buxtehude | Germany | ||
13 | Uniklinik Köln | Cologne | Germany | ||
14 | Klinikum Dortmund | Dortmund | Germany | ||
15 | SRH Wald-Klinikum Gera | Gera | Germany | ||
16 | Universitätsmedizin Göttingen | Göttingen | Germany | ||
17 | Universitaetsklinikum Halle | Halle (Saale) | Germany | ||
18 | Universitaetsklinikum Hamburg-Eppendorf | Hamburg | Germany | ||
19 | Universitaetsklinikum Schleswig-Holstein (UKSH), Campus Kiel | Kiel | Germany | ||
20 | HELIOS Klinikum | Krefeld | Germany | ||
21 | Klinikum der Stadt Ludwigshafen am Rhein | Ludwigshafen am Rhein | Germany | ||
22 | Universitätsklinikum Schleswig-Holstein | Lübeck | Germany | ||
23 | Universitätsklinikum Mannheim | Mannheim | Germany | ||
24 | Johannes Wesling Klinikum Minden | Minden | Germany | ||
25 | Universitäts-Hautklinik Tübingen | Tübingen | Germany | ||
26 | Universitätsklinikum Ulm | Ulm | Germany | ||
27 | ATTIKON Hospital and Cutaneous Lymphoma Clinic | Athens | Greece | ||
28 | Universita Di Firenze | Firenze | Italy | ||
29 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milano | Italy | ||
30 | Universita Cattolica del Sacro Cuore | Roma | Italy | ||
31 | IFO San Gallicano | Rome | Italy | ||
32 | Ospedale Molinette | Turin | Italy | ||
33 | Niigata University Medical and Dental Hospital | Niigata | Japan | ||
34 | Okayama University Hospital | Okayama | Japan | ||
35 | Tohoku University Hospital | Sendai | Japan | ||
36 | Hamamatsu University School of Medicine | Shizuoka | Japan | ||
37 | University of Tsukuba Hospital | Tsukuba | Japan | ||
38 | Leids Universitair Medisch Centrum (LUMC) | Leiden | Netherlands | ||
39 | Medical University of Gdansk | Gdansk | Poland | ||
40 | SP ZOZ Szpital Uniwersytecki w Krakowie | Kraków | Poland | ||
41 | Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie | Warsaw | Poland | ||
42 | Uniwersytecki Szpital Kliniczny im. WAM - CSW | Łódź | Poland | ||
43 | Hospital Del Mar | Barcelona | Spain | ||
44 | Hospital Duran i Reynals | Barcelona | Spain | ||
45 | Hospital Universitario 12 de Octubre | Madrid | Spain | ||
46 | Hospital Uni. Nuestra Senora de Candelaria | Tenerife | Spain | ||
47 | Hospital General Universitario | Valencia | Spain | ||
48 | Centre hospitalier universitaire vaudois (CHUV) | Lausanne | Switzerland | ||
49 | Kantonsspital St. Gallen | St. Gallen | Switzerland | ||
50 | Universitätsspital Zürich | Zürich | Switzerland | ||
51 | University Hospital | Birmingham | United Kingdom | ||
52 | Beatson West of Scotland Cancer Centre | Glasgow | United Kingdom | ||
53 | St John's Institute Of Dermatology - Guy's & St Thomas' Nhs Foundation Trust | London | United Kingdom | ||
54 | Christie Hospital | Manchester | United Kingdom |
Sponsors and Collaborators
- 4SC AG
Investigators
- Principal Investigator: Rudolf Stadler, Prof., Johannes Wesling Klinikum, Minden, Germany
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 4SC-201-6-2015
- 2016-000807-99