CTRI/2020/03/024065Other1 期
A Randomized, Open Label, Two Period, Single Dose, Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Suspension (PICS) in Subjects with Locally Recurrent or Metastatic Breast Cancer (MBC).
试验速览
- 阶段
- 1 期
- 状态
- Other
- 入组人数
- 44
- 试验地点
- 23
- 主要终点
- Maximum observed plasma concentration Plasma, area under the plasma concentration versus time curve, from time 0 to the last measurable concentration and area under the plasma concentration versus time curve from time 0 to infinity of PICS under various reconstitution conditions.
研究概览
简要总结
This is a randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of PICS in Locally Recurrent or Metastatic Breast Cancer subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1. The subject has given written, informed consent (or legally acceptable representative /impartial witness when applicable) and is available for the duration of study
- •Histologically or cytologically confirmed diagnosis of breast cancer with adequate documentation of prior therapy with an anthracycline unless clinically contraindicated
- •Locally recurrent or MBC for which taxane-based therapy is an appropriate treatment option
- •Male or female aged greater than equal to 18 years
- •ECOG performance status less than equal to 1
- •Estimated life expectancy of at least 12 weeks
- •Adequate organ and immune system function as indicated by the following laboratory values, obtained less than equal to 2 weeks prior to dosing for Period 1 and Period 2:
- •Any chemotherapy, targeted therapy, major surgery, or irradiation must have been completed at least 4 weeks before enrollment (6 weeks for mitomycin C or nitrosurea); immune therapy or hormonal therapy (except palliative bisphosphonate therapy for bone pain) must be completed 2 weeks before enrollment and subjects must have recovered from all toxicities incurred as a result of previous therapy except alopecia; use of targeted therapy or antibody therapy should have been completed for at least 5 half-lives of the respective therapy before enrollment.
- •Use of narcotic analgesics such as dihydrocodeine and medicinal herbs such as St. John’s Wort, which may act as inhibitors/inducers of CYP2C8 and CYP3A4, must have been discontinued at least 2 weeks and 4 weeks respectively before enrollment
- •Subjects of child bearing potential must practice an acceptable method of birth control as judged by the investigator • Medically acceptable methods of birth control include the use of either a contraceptive implant or a contraceptive injection (e.g., Depo-Proveraâ„¢) or an intrauterine device, same sex partner or vasectomized partner or an oral contraceptive taken continually within the past three months and which the subject agrees to continue using during the study • To adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or a spermicide at least 2 months prior to study entry and must continue to use contraception for the duration of the study
- •Female subjects who are postmenopausal for at least 1 year as per investigator’s discretion, or who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject)
- •Male subjects enrolled in the trial cannot father a child and are advised to prevent passage of semen to their sexual partner during intercourse using acceptable methods as judged by the investigator for the duration of the study
- •Females subjects of child-bearing potential must have a negative urine pregnancy test
- •Female subjects must be non-lactating and non-breastfeeding
- •Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing.
排除标准
- •Known hypersensitivity to the study drug or their excipients (cholesteryl sulfate, caprylic acid, polyvinylpyrrolidone, ethanol, polyethylene glycol)
- •Inability to undergo venipuncture and/or tolerate venous access
- •Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy
- •Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 5.0)
- •Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study or confound the study
- •Presence of pleural/ascitic fluid which cannot be definitively treated prior to dosing and during the PK blood draws in each period (Period 1 and Period 2) and if there is re-accumulation of fluid (greater than 5%) greater than 2 weeks after definitive management
- •Positive laboratory exclusion test (HIV, HBsAg, or HCV)
- •Failure of prior taxane therapy for metastatic disease or for adjuvant therapy within previous 6 months of screening visit
- •Subjects taking concurrent medications that may act as inhibitors/inducers of CYP2C8 and CYP3A4 within 2 weeks of screening and during Periods 1 and 2
- •Evidence or history of bleeding diathesis or coagulopathy within 6 months prior to screening visit
- •Uncontrolled cardiac disease, including: congestive heart failure (CHF) > Class II per New York Heart Association (NYHA), history of hypertensive crisis
- •Active clinical infection which in the treating investigator’s opinion renders the subject ineligible or can confound the study
- •Serious non-healing wound, ulcer or bone fracture
- •Unresolved toxicity higher than CTCAE Version 5.0 Grade 1 (excluding alopecia, anemia) attributed to any prior therapy/procedure
- •History of gastrointestinal perforation within 6 months prior to screening visit.
结局指标
主要结局
Maximum observed plasma concentration Plasma, area under the plasma concentration versus time curve, from time 0 to the last measurable concentration and area under the plasma concentration versus time curve from time 0 to infinity of PICS under various reconstitution conditions.
时间窗: 8 weeks
次要结局
- number of subjects with treatment emergent adverse events(safety and tolerability profile of PICS under various reconstitution conditions)
研究者
研究点 (23)
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