The purpose of this research study is to determine if the new drug resminostat will be able to delay or prevent worsening of disease in patients with advanced stage mycosis fungoides or Sézary Syndrome that have achieved disease control with previous systemic therapy, recently

Phase 1

• Conditions: Advanced stage (Stage IIB-IVB) mycosis fungoides (MF) or Sézary Syndrome (SS) that have achieved disease control with systemic therapy; MedDRA version: 19.0Level: LLTClassification code 10028508Term: Mycosis fungoides/Sezary syndromeSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2016-000807-99-ES
• Lead Sponsor: 4SC AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-05
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1.Patients with histologically confirmed MF (Stage IIB-IVB) or SS in an ongoing CR, PR or SD after at least one prior systemic therapy according to local standards (including but not limited to a-interferon, bexarotene, total skin electron beam irradiation, chemotherapy)
othe 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.Written informed consent obtained prior to any trial specific procedure
4.Eastern Cooperative Oncology Group (ECOG) status score 0-2
5.Adequate haematological, hepatic and renal function, as demonstrated by:
a)haemoglobin = 9.0 g/dl (International System [SI] of Units: 5.6 mmol/L)
b)absolute neutrophil count = 1,000/mm3
c)platelets = 75 × 109/L
d)alanine aminotransferase and aspartate amino-transferase = 2 times upper limit of normal
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 International Normalised Ratio = 2.3
6.Women of childbearing potential (not post-menopausal for 1 year and not surgically sterile) and males with partners of childbearing potential must be sexually abstinent or must use effective double contraception (at least two of the following: hormonal contraceptives [e.g., injection, implant, patch], diaphragm, intrauterine device, and condoms [for the male partner]) from the time of screening to 30 days (female patients) or 3 months (male patients) after the last dose of trial treatment
7.Adequate recovery from precedent non-haematological toxicities, excluding alopecia, to = National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 1
8.Able to comply with all the requirements of the protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

1.Patients with PD
2.Known central nervous system involvement
3.History and current cardiovascular complications, including unstable angina pectoris, uncontrolled hypertension, congestive heart failure (New York Heart Association [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 corrected QT (QTc) interval > 500 milliseconds
5.History of additional risk factors for 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 or 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 drugs
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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified