Exploratory Study to Evaluate the Safety and Efficacy of CD5789 in Subjects With Early Stage Cutaneous T-Cell Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Tolerance Score of CD5789 0.01% Cream
研究概览
简要总结
The goal of this clinical research study is to learn if CD5789 is safe and tolerable when given to patients with early stage CTCL.
CD5789 is designed to attach to tumor cells and change their genetic material. This may stop the growth of the tumor cells.
详细描述
Study Drug Administration:
If you are found to be eligible to take part in this study, you will apply CD5789 cream 1 time each day. You should do this after you wash the area.
During your first study visit, the study staff will select which lesions you will apply cream to. The study staff will tell you how much cream to apply.
On Day 1, the study staff will apply the study drug on half of the lesions. You will apply the study drug to the rest of the lesions while the study staff watches. In a diary, the study staff will write down the time you applied the study drug. You must write down this information in the diary when you apply the study drug at home. On your Week 1 visit, you will apply the study drug at the clinic while the study staff watches.
You will use gloves to apply the study drug in a thin film on the lesions. Be careful not to overlap healthy skin. You should massage the study drug gently into the skin. If someone helps you apply the study drug, they must also wear gloves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject is a male or female, who is at least 18 years of age at Screening visit.
- •The Subject has a clinical diagnosis of stable CTCL early stage (IA-IIA). The subject has :a) A known stable TNMB stage (cancer classification based on analysis of Tumors, Nodes, Metastasis and Blood), or b) Stable patch or plaque lesions that have not responded to topical treatment with corticosteroids or nitrogen mustard or which have relapsed after prior therapy.
- •The Subject presents at least 3 distinct lesions (one selected as index lesion, one dedicated to biopsy and another one dedicated to tape-stripping).
- •If the Subject is a female of childbearing potential, she agrees to use a highly contraceptive method for the duration of the study and for one month after the last product application. A highly effective method of contraception is defined by: 1) Bilateral tubal ligation 2) Combined oral contraceptives (estrogen and progesterone) implanted or injectable contraceptives, on a stable dose for at least 1 month prior to screening visit, 3) Hormonal intra-uterine device (IUD), inserted at least one month prior to the Screening visit.
- •If the Subject is female of childbearing potential, she has at Screening (at least 14 days before Baseline) and at Baseline a negative result for urine pregnancy test (UPT)having a sensitivity down to at least 25 Ul/ml for human chorionic gonadotrophin (hCG).
- •If the Subject is a female of non-childbearing potential, she has to be postmenopausal (absence of menstrual bleeding for at least one year and without any other medical reason), or presenting with a hysterectomy or a bilateral ovariectomy.
- •The Subject is willing and able to comply with all of the time commitments and procedural requirements of the clinical trial protocol.
- •The Subject has understood and signed an Informed Consent Form (ICF) at Screening, prior to an investigational procedures being performed.
- •The Subject is apprised of the Health Insurance Portability and Accountability Act (HIPAA), and is willing to share personal information and data, as verified by signing a written authorization at the screening.
排除标准
- •The subject has any uncontrolled or serious disease (other than CTCL), or any medical or surgical condition, that may either interfere with the interpretation of the clinical trial results, and/or put the subject at significant risk (according to Investigator's judgment) if he/she participates in the clinical trial.
- •The subject has known or suspected allergies or sensitivities to any components of the study drug (see Investigator's Brochure).
- •The subject, if female, has a positive urinary pregnancy test, is breast-feeding or is planning a pregnancy during the course of the study.
- •If the subject needs a relative to apply the study product, the relative is a female who is pregnant, lactating or intends to conceive during the clinical study or within 1 month after the last product application.
- •The subject is in an exclusion period from a previous clinical study, takes part into any other clinical trial of a drug or device, OR participated within 1 month prior to baseline.
- •The subject has used any of the following treatments or procedure before the first study treatment application (Baseline) within the wash-out periods defined below: corticoids or Aldera (imiquimod) 4 weeks; retinoids, nitrogen mustard (mechlorethamine), Carmustine (BCNU), or phototherapies 2 weeks, any systemic treatment dedicated to CTCL within 4 weeks.
- •The subject is unwilling to refrain from use of prohibited medication during the clinical trial.
- •The subject has an abnormal ECG judged clinically significant by the investigator and/or PR interval outside the range of 120 ms to 220 ms, QRS>120 ms, and corrected QT interval (QTc)>450 ms.
- •The subject presents seropositivity for hepatitis B surface antigen(HBsAG), hepatitis C virus (HCV) antibody and /or human immunodeficiency virus (HIV) 1 and 2 antibody.
- •The subject is vulnerable (such as deprived of freedom) as defined in Section 1.61 of International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (GCP).
研究组 & 干预措施
CD5789 0.01% Cream
CD5789 0.01% cream applied on the lesions once daily for twelve weeks.
干预措施: CD5789 0.01% Cream (Drug)
结局指标
主要结局
Tolerance Score of CD5789 0.01% Cream
时间窗: 12 weeks
Data analysis based on local tolerability score evaluated at each visit with a worst tolerance score for the subject calculated at each visit. Worst tolerance score is worst score of local tolerability of all index lesions for each subject at each visit. Worst tolerance score (max local tolerance score) summarized in frequency tables to follow the evolution of this score across visits for each subject. Index lesion(s) evaluated at each visit for local tolerance (using a 5-point scale) from Week 1 visit to Week 12/ Early Termination visit for each index lesion. Tolerance 5-point scale from 0-No reaction to 4-Severe where the higher number the worse reaction.
次要结局
未报告次要终点