NCT05229042已完成1 期
An Exploratory Study to Investigate the Safety and Efficacy of Ricolinostat for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Beijing 3E-Regenacy Pharmaceuticals Co., Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- TEAT
研究概览
简要总结
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
详细描述
This is a double-blind, placebo-controlled study during which patients will receive ricolinostat or placebo.
Prior to randomization, patients will participate in the Screening and Baseline assessment period to ensure that they meet study inclusion/exclusion criteria.
Following the Screening and Baseline assessment period, patients who meet entry criteria will be randomized in a 2:1 ratio to receive either ricolinostat or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blank
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand the study's purpose and requirements, and able to voluntarily provide informed consent to participate.
- •Age ≥ 18 years and < 70 years at the time of signing the informed consent form (ICF).
- •Female patients diagnosed with breast cancer:
- •Who have been treated with either docetaxel or paclitaxel.
- •Who have a Karnofsky performance status of 70 or more at Screening.
- •Who have completed their chemotherapy at least 1 month prior to randomization.
- •Neuropathy of <Grade 4 using the general guideline of grading scales defined in Common Terminology Criteria for Adverse Events (CTCAE; v5.0) .
- •Women of childbearing potential (WOCBP) must agree to use reliable contraceptive methods for the duration of the study and for at least 3 months after completing treatment with study drug. For the purposes of this study, reliable methods of contraception include abstinence, oral contraceptives, hormonal contraceptive implants such as Nexplanon, hormonal vaginal ring such as NuvaRing, intrauterine devices in place for at least 3 months, or barrier methods used in conjunction with spermicide. To be considered post-menopausal and of non childbearing potential, women less than 60 years with less than 2 years since their last period must have follicle-stimulating hormone (FSH) > 40 IU/L and estradiol < 20 pg/mL unless on hormone replacement.
- •Able to adhere to the study visit schedule and other protocol requirements.
排除标准
- •Women who are pregnant or lactating.
- •Extremely overweight, defined as body mass index (BMI) > 40 kg/m
- •Presence of any neuropathy other than CIPN.
- •Presence of a clinical condition commonly associated with neuropathy that could better account for the presence of the patient's neuropathy, such as diabetes or a risk factor for marked B12 deficiency (malabsorption syndrome, atrophic gastritis, strict vegan diet, etc.), or a megaloblastic (macrocytic) anemia consistent with B12 deficiency.
- •Presence of skin conditions in the affected dermatome that, in the judgement of the Investigator, could interfere with evaluation of the neuropathic pain condition.
- •Presence of non-CIPN pain that may interfere with study assessments and/or self-evaluation of peripheral neuropathic pain.
- •History of alcoholism or drug/chemical abuse within 1 year prior to randomization as judged by the Investigator based on clinical history.
- •Opioid use at a dose of ≥ 30 morphine milligram equivalents on 3 or more days a week during the month at Screening.
- •The use of cannabidiol (CBD) during the 1 month at Screening.
研究组 & 干预措施
Active arm
Active Comparator
Subjects received ricolinostat
干预措施: Ricolinostat (Drug)
Placebo arm
Placebo Comparator
Subjects received placebo
干预措施: Ricolinostat (Drug)
结局指标
主要结局
TEAT
时间窗: 6 months
The primary endpoint is the incidence of treatment-emergent adverse events (TEAEs) during the Treatment period.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B VaccineHepatitis B, ChronicNCT04289987CHA Vaccine Institute Co., Ltd.134
已完成
2 期
Study of Leptin for the Treatment of Hypothalamic AmenorrheaAmenorrheaNCT00130117Beth Israel Deaconess Medical Center20
已完成
2 期
Efficacy And Safety Of GW642444M Comparing Placebo In Adolescent And Adult Subjects With Persistent Asthma.AsthmaNCT00600171GlaxoSmithKline614
已完成
1 期
Single and Multiple Ascending Oral Dose Study of RX-10001 in Healthy VolunteersHealthyNCT00941018Resolvyx Pharmaceuticals, Inc56
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsCystic FibrosisNCT02190604Novartis Pharmaceuticals153