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4SC-RESMAIN Studie

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2016-000807-99

A multicentre, double blind, randomised, Placebo-controllend, Phase II Trial to evaluate Resminostat for maintenance Treatment of patients with advanced stage (stage IIB-IVB) mycosis fungoides (MFI or Sezary Syncdrome (SS) that have achieved disease control with systemic therapy - the RESMAIN Study

Status: Active

Purpose / Objectives

Primary Outcome

The Primary objective is to determine if maintenance Treatment with resminostat increases Progression free survival (PFS) compared to Placebo.

Diagnosis

Patients with advanced stage (Stage IIb-IVb) Mycosis fungoides (MF) or Sezary Syndrome that have achieved disease control with systemic therapy.

Patient attributes

Stage

IIb-IVb

Age

18-99

Inclusion criteria

1. Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing CR, PR or SD after at least 1 Prior systemic therapy according to local Standards  (including but not limited to α-Interferon, bexarotene, total Skin electron beam Irritation, chemotherapy).         

- the most recent systemic therapy must have been completed as planned or stopped due to unacceptable toxicity 2-8 weeks Prior to randomisation.

2. Male or female ≥ 18 years.

3. Writtten informed consent obtained Prior to any Trial specific procedure.

4. Eastern coperative oncology Group (ECOG) Status score 0-2.

5. Adequate haematological, hepatic and renal function, als demonstrated by:

a.) haemoglobin ≥ 9.0 g/dl (SI Units: 5.6 mmol/L)

b.) absolute neutrophil Count ≥ 1,000 m3

c.) platelets ≥ 75 x 109/L

d.) Alanine aminotransferase  (ALT) and aspartate amino-transferase (AST) ≤ 2 times upper Limit of normal (ULN)

e.) total Bilirubin 2 mg/dl (SI Units: 0.117 µmol /L) (unless known Gilbert Syndrome)

f.) Serum creatinine ≤ 1,5 mg/dL (SI Units: 132 µmol /L)

g.) prothrombin time (PT) International Normalized  Ratio (INR) ≤ 2.3

6. Women of childbearing  potential (not post-menopausal for 1 year and not surgically sterile) and sexually active males (unless surgically vasectomised) must use highly effective method of birth control from the time of Screening to 30 days after the last Trial Treatment.

7. Adequate recovery from precedent non-haematological toxicities, excluding alopecia, to ≤ CTCAE Grade 1

8. Able to comply with all the requirements of the protocol.                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     

Exclusion criteria

1. Patients with PD

2. Known central nervous System (CNS) involvement

3. History and current cardiovascular complications, including unstable Angina pectoris, uncontrolled Hypertension, congestive heart failure (NYHA Class III or IV) related to Primary cardiac disease, a condition requiring anti arrhythmic therapy, ischemic or severe valvular heart disease, or a myocardial infarction within 6 months Prior to randomisation.

4. Baseline QTc interval > 500 millliseconds

5. History of additonal risk factors to Torsade de Pointes (e.g., heart failure, hypokalaemia, Family history of Long QT Syndrome)

6. Use of concomitant medications that are known to prolong the QT/QTc interval.

7. Concurrent use of any other specific anti-tumour therapy including psoralen photo chemotherapy (PUVA), chemotherapy, immunotherapy, hormonal therapy, Radiation therapy, or experimental medications.

8. Previous and concurrent cancer that is distinct in Primary site or histology from CTCL, except cervical carcinoma in situ, treated basal cell carcinoma, superficial bladder tumours (TA, Tis and T1); any cancer curatively treated > 3 years Prior to randomisation will be allowed.

9.Current evidence of any uncontrolled clinically significant internal, psychiatric or neurologic disease.

10. Altered mental Status precluding understanding of the informed consent process and/or completion of the necessary Trial procedures.

11. Pregnant or breast feeding women

12. History of allergic reactions attributed to compounds of similar chemical or biological composition to the Trial drug.

13. Active alcohol and/or drug abuse

14. Any other acute or chronic condition that, in the investigator's opinion, would Limit the patient's ability to complete or participate in this Trial.

 

 

Trial design

  • Phase II
  • Multicenter
  • Randomized
  • Two-arm
  • Double-blind
  • Placebo-controlled

Documents (password protected)

Responsibilities in overall trial

4SC AG

  • Tel. +49-89-700763-0
  • Fax +49-89-700763-29

National Coordinating Investigator

Prof. Dr. med. Josef Stadler

Study Sites

Klinik & Poliklinik für Dermatologie & Venerologie Köln

Study office

Status

Active

Principal Investigator

Univ.-Prof. Dr. med. Dr. Cornelia Mauch

Deputy of Principal Investigator

  • Dr. Nicole Kreuzberg

Subinvestigator

  • Dr. Nicole Kreuzberg

Contact at Site