A Dose-regimen Finding Study to Evaluate Safety, Tolerability, Pharmacokinetics and Activity of Oraxol in Subjects With Advanced Malignancies
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 3
- 主要终点
- To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
研究概览
简要总结
This is a standard "3+3" Phase 1b study to determine the MTD of Oraxol (paclitaxel + HM30181 Methanesulfonate monohydrate) in subjects with advanced malignancies that may be metastatic or unresectable with measurable malignant lesion(s) per RECIST Version 1.1 criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Signed written informed consent
- •≥ 18 years of age
- •Histologically or cytologically confirmed solid tumor that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- •Measurable disease as per RECIST Version 1.1 criteria.
- •Adequate bone marrow reserve as demonstrated by
- •Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L
- •Platelet count ≥ 100 x 10⁹/L
- •Hemoglobin (Hgb) ≥ 9 g/L
- •Adequate liver function as demonstrated by
- •Total bilirubin of ≤ 1.5 mg/dL or ≤ 2.0 mg/dL for subjects with liver metastasis
- •Alanine aminotransferase (ALT)≤ 3 x upper limit of normal (ULN) or ≤ 5x ULN if liver metastasis is present
- •ALP ≤ 3 x ULN or ≤ 5 x ULN if bone metastasis is present
- •Adequate renal function as demonstrated by serum creatinine ≤ 1.5 x ULN, or 24-hr urine creatinine clearance calculation >60 mL/min
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Life expectancy of at least 3 months
- •Subjects who are not currently taking prohibited medication
- •Women must be postmenopausal (> 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective contraception
排除标准
- •Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational agents
- •Received investigational agents within 14 days or 5 half-lives of the first study dosing day, whichever is longer.
- •Women of childbearing potential who are pregnant or breast feeding.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, myocardial infarction within the last 6 months, unstable angina pectoris, cardiac arrhythmia, chronic pulmonary disease requiring oxygen, known bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements
- •Significant or uncontrolled cardiovascular disease or bleeding disorder
- •Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease or other medical condition that, in the opinion of the investigator may interfere with oral drug absorption
- •Subjects with a known history of allergy to paclitaxel. Subjects whose allergy was due to the IV solvent (such as Cremophor®) and not paclitaxel will be eligible for this study.
研究组 & 干预措施
Oraxol Arm 1
HM30181AK-US tablet administered as a single oral dose of xmg on Days x, y, and z of each cycle
Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.
干预措施: Oraxol (Drug)
Oraxol Arm 2
HM30181AK-US tablet administered as a single oral dose of xmg daily with each dose of Paclitaxel
Paclitaxel administered as a fixed oral daily dose of xmg (nine xmg capsules) starting on Days x, y, and z of each cycle. Depending on the cohort, subjects will receive 2, 3, 4, or 5 consecutive days of paclitaxel per week.
干预措施: Oraxol (Drug)
结局指标
主要结局
To determine the maximum tolerated dose (MTD) of Oraxol in subjects with advanced malignancies
时间窗: one year
次要结局
- To determine the recommended Phase 2 dose (RP2D) of Oraxol(one year six months)