Phase I Study of CM082 in Patients With Myopic Choroidal Neovascularization (CNV)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Dose-Limiting Toxicity(DLT)
研究概览
简要总结
This is a Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Intermittent Oral Dosing of CM082 tablets in Chinese Patients With mCNV.
详细描述
This is a multicenter, open-label, single-arm, phase I Study to Evaluate the safety, tolerability, pharmacokinetics and preliminary Efficacy of intermittent oral dosing of CM082 tablets in Chinese patients with mCNV. The study will be performed in two different parts, dose-escalation phase (Part 1) and dose-expansion phase (Part 2). Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles. There are three dose levels, 25mg BID,50mg QD and 50mg BID. The total treatment period is tentatively set at 3 cycles (12 weeks). Based on data from dose escalation studies, identify safe and effective doses for expanded enrollment studies.The assessment of the safety and efficacy will be done in 2、4、8、12weeks after the first dose.Also, single/multiple dose pharmacokinetics in these patients will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of active CNV secondary to pathologic myopia and the study eye must have the following lesion characteristics: (a)presence of high myopia with greater than -6 diopters of spherical equivalencef or anteroposterior elongation greater than 26 mm, (b) presence of at least 1 of the following lesion types: subfoveal; juxtafoveal; extrafoveal with involvement of the central macular area and margin of the optic disk with involvement of the central macular area, (c) vision loss due to the above causes, (d) ETDRS BCVA 24 to 78 letters.
- •Patients with no previous anti-VEGF therapy.
- •Adequate bone marrow, hepatic, and renal functions.
- •Willing to sign the ICF and comply with the study protocol.
排除标准
- •CNV due to causes other than mCNV.
- •Any significant disease in the study eye that could compromise BCVA.
- •Active eye infection in any eye.
- •Previous treatment with photodynamic therapy (PDT), external beam radiation, laser photocoagulation, or transpupillary thermotherapy within
- •1 month of the first dose.
- •Intraocular surgery in the test eye within 3 months prior to the first dose.
- •Any eye received intravitreal injection of corticosteroids within 3 months prior to first dose.
- •Clinically significant, uncontrolled cardiovascular and cerebrovascular disease.
- •Patients who had previously used strong inhibitors of CYP3A or strong inducers were discontinued from the first dose of CM082 <5 drug half-lives (except for withdrawals longer than 14 days).
- •Active hepatitis B (serum HBV DNA ≥ 500 IU / ml), hepatitis C antibody positive, HIV antibody positive or syphilis antibody positive.
- •Swallowing dysfunction, active gastrointestinal disease, or other diseases that affect the absorption, distribution, metabolism, and excretion of drugs.
- •Use of any investigational agent or participation in any other clinical trial of an investigational agent or investigational therapy within thirty (30) days of the first dose.
- •Allergy to the ingredients of the study drug.
- •Patients who have fertility needs and who cannot use effective methods of contraception during the study period and at least 3 months after the end of treatment (except for male patients after birth control or female patients after birth control or postmenopausal).
研究组 & 干预措施
CM082 Tablet
Code Name: CM082 Tablet Other Name: X-82 Dosage and Administration: 25mg BID/50mg QD/50mg BID, P.O., two-week on/two-week off in four-week cycles until disease progression or unacceptable toxicity
干预措施: CM082 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity(DLT)
时间窗: the first cycle(the first four weeks)
Any serious adverse event in eye or any ≥3 grade adverse reactions cannot be reduced to below grade 3 after treatment for more than 7 days.
Adverse event
时间窗: 12 weeks
Incidence of the adverse event after treatment
次要结局
- Change in Best-Corrected Visual Acuity (BCVA)(12 weeks)
- Change in Choroidal Neovascularization (CNV) size(12 weeks)
- Change in Central Retinal Thickness(12 weeks)