ACTRN12615000881538已完成2 期
A Safety Study of Oraxol (HM30181 + oral paclitaxel) in Cancer Patients
Kinex Pharmaceuticals Inc0 个研究点目标入组 44 人开始时间: 2015年8月24日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
研究概览
简要总结
Trial not completed
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Eligible participants are cancer patients for whom treatment with IV paclitaxel at 80 mg/m2 has been recommended by their oncologist, either as monotherapy or in combination with other agents.
- •At Screening/Baseline, they must have
- •Adequate hematologic status:
- •- Absolute neutrophil count (ANC) greater than/equal to 1.0 x 10^9/L
- •- Platelet count greater than/equal to 100 x 10^9/L
- •- Hemoglobin greater than/equal to 90g/L
- •Adequate liver function as demonstrated by:
- •- Total bilirubin of less than/equal to 20 micromol/L or less than/equal to 30 µmol/L for participants with liver metastasis
- •Alanine aminotransferase (ALT) less than/equal to 3 x upper limit of normal (ULN) or less than/equal to 5 x ULN if liver metastasis is present
- •Alkaline phosphatase (ALP) less than/equal to 3 x ULN or less than/equal to 5 x ULN if liver or bone metastasis is present
- •Adequate renal function as demonstrated by serum creatinine less than/equal to 177 micromol/L or creatinine clearance greater than 50 mL/min as calculated by the Cockroft and Gault formula.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; and life expectancy of at least 3 months.
- •They must be willing to fast for 8 hours before and 4 hours after Oraxol administration; willing to abstain from alcohol consumption for 3 days before the first dose of Oraxol through the completion of protocol specified PK sampling for that treatment week; willing to refrain from caffeine
- •consumption for 12 hours before the first dose of Oraxol through the completion of protocol-specified PK sampling for that treatment week. Women must be postmenopausal (more than 12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or, if sexually active, must be using effective contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for the duration of their participation in the study. Women of childbearing potential must agree to use contraception for 30 days after their last dose of study drug. Sexually active male participants must use a barrier method of contraception during the study and agree to continue the use of male contraception for at least 30 days after the last dose of study drug.
排除标准
- •Study participants must not be:
- •Currently taking a prohibited concomitant medication;
- •- a medication known to be a P-gp inhibitor (e.g., verapamil) or inducer (rifampin) within 7 days prior to the first dose of Oraxol
- •- an oral medication with a narrow therapeutic index known to be a P-gp substrate (eg, digoxin or dabigatran) within 24 hours prior to the first dose of Oraxol
- •- a medication known to be a strong CYP3A4 strong inhibitor (e.g., ketoconazole) or strong inducer (e.g., rifampin or St. John's Wort) within 14 days prior to the first dose of Oraxol
- •- a medication known to be a strong inhibitor (e.g., gemfibrozil) or inducers (e.g., rifampin) of CYP2C8 within 14 days prior to the first dose of Oraxol
- •Other exclusions are: unresolved toxicity from prior chemotherapy;
- •have received investigational agents within 14 days or 5 half-lives prior to the first study dosing day, whichever is longer. Other exclusions are women of childbearing potential who are pregnant or breast feeding; uncontrolled intercurrent illness; major surgery to the upper gastrointestinal 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; known history of allergy to paclitaxel (Participants whose allergy was due to the IV solvent (such as Cremophor [Registered Trademark]) and not paclitaxel will be eligible for this study); any other condition which the investigator believes would make a subject’s participation in the study not acceptable.
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