An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 29
- 试验地点
- 3
- 主要终点
- Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.
研究概览
简要总结
This is multicenter, open-label, 2-part crossover study. Eligible subjects will have metastatic or unresectable solid tumors. This study includes a pretreatment and treatment phase. The pretreatment phase consists of screening and baseline. The treatment phase consists of Periods 1 and 2 (Part A), Treatment (Part B), and Follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •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 v1.1 criteria
- •Adequate hematologic status
- •Adequate liver function.
- •Adequate renal function
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- •Life expectancy of at least 3 months.
- •Women must be postmenopausal or surgically sterile.
- •Sexually active male subjects must use a barrier method of contraception during the study.
- •Able to consume the prescribed meals
排除标准
- •Have not recovered to ≤ Grade 1 toxicity from previous anticancer treatments or previous investigational products (IPs).
- •Received IPs within 21 days or 5 half-lives of the first dosing day, whichever is shorter
- •Are currently receiving other medications or radiation intended for the treatment of their malignancy. Hormonal therapy is allowed.
- •Women of childbearing potential who are pregnant or breastfeeding.
- •Currently taking a concomitant medication, other than a premedication, that is:
- •A strong P-glycoprotein (P-gp) inhibitor or inducer.
- •An oral medication with a narrow therapeutic index known to be a P-gp substrate.
- •Medications known to be strong inhibitors or inducers of cytochrome P450 (CYP) 2C8 or medications known to be strong CYP3A4 inhibitors or inducers.
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, or any concomitant illness that would limit compliance with study requirements.
- •Major surgery to the upper gastrointestinal (GI) tract, or have a history of GI disease that may interfere with oral drug absorption.
- •Cirrhosis of the liver or known active hepatitis B, hepatitis C, or HIV
- •History of hypersensitivity to paclitaxel, not attributed to a hypersensitivity-type reaction to Cremophor
研究组 & 干预措施
Fed/ Fasted Treatment Sequence
Subjects will be assigned a fed/fasted sequence.
Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.
Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.
干预措施: Oraxol (Drug)
Fasted/ Fed Treatment Sequence
Subjects will be assigned a fasted/fed sequence.
Fasted Sequence- subjects will fast overnight and continue fasting until 4 hours post paclitaxel dose.
Fed sequence- subjects will fast overnight and continue fasting until they consume a standardized test meal at a predetermined time after paclitaxel administration.
干预措施: Oraxol (Drug)
结局指标
主要结局
Comparison of the concentration-time profile of Oral Paclitaxel in plasma for 168 hours when taken with or without food.
时间窗: 24 months
次要结局
- Incidence of Adverse Events (Safety and Tolerability)(24 months)
- Comparison of the concentration-time profile of HM30181 in plasma for 168 hours when taken with or without food.(24 months)
- The proportion of patients with tumor responses after the initiation of treatment.(At baseline and every 8 weeks through study completion, approximately 24 months)