EUCTR2016-000807-99-ES进行中（未招募）1 期
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 - RESMAIN Study
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 4SC AG
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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