CTRI/2020/06/025512进行中（未招募）未知
A randomized, open label, balanced, multicenter, two-treatment, two-period, two-sequence, two-way crossover, single dose, bioequivalence study with pharmacokinetic endpoints of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) 100 mg/vial at a dose of 260 mg/m2 with ABRAXANE® for Injectable Suspension (albumin--bound) 100 mg/vial at a dose of 260 mg/m2 in Breast cancer subjects after failure of combination chemotherapy for metastatic disease. - NA
ingbo Shouzheng Medicinal Research Co Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Ba/be
入排标准
入选标准
- •Female subjects will be considered eligible for the study based on the following criteria:
- •1. Willing and able to provide voluntary informed consent and to follow the protocol requirements.
- •2. Females aged 18 to 65 years (both inclusive) having Body Mass Index BMI at least 17.00 calculated as weight in kg per height in m2.
- •3. Subjects with histopathologically or cytologically confirmed breast cancer
- •4. Subjects with breast cancer after failure of combination chemotherapy for metastatic disease or having relapse within 6 months of adjuvant chemotherapy. (Prior therapy should have included an anthracycline unless clinically contraindicated)
- •5. Eastern Cooperative Oncology Group (ECOG) performance status Less or equal to 2.
- •6. Life expectancy of at least 3 months at the time of enrolment.
- •7. Acceptable hematology status:
- •a. Hemoglobin greater or equal to 9.0 g per dL
- •b. Absolute neutrophil count ANC greater or equal to 1500 cells per mm3
- •c. Platelet count greater or equal to 1, 00,000 cells per mm3
- •8. Acceptable liver function:
- •a. Alanine aminotransferase ALT Less or equal to 2.5 X ULN
- •b. Aspartate aminotransferase AST Less or equal to 2.5 X ULN
- •c. Bilirubin less or equal to 1.5 X ULN
- •d. Alkaline phosphatase less or equal to 5 X ULN
- •9. Subjects with Creatinine clearance greater or equal to 60 mL per minute
- •10. Subjects with negative serum pregnancy test at screening and negative urine pregnancy test at Day 0.
- •11. Women of child bearing potential (defined as women physiologically capable of becoming pregnant, unless they are using effective method of contraception during dosing of the investigational product) practicing acceptable methods of contraception. Acceptable methods of contraception are
- •a. Hormonal method (including oral, vaginal ring, transdermal patch, implanted or injection) started at least 7 days prior to day 0 plus one barrier method (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, female or male condom
- •b. Intrauterine device IUD or intrauterine system IUD or IUS placed 7 days prior to day 0
- •c. Two barrier method used together (cervical cap, diaphragm, contraceptive sponge, vaginal spermicide, male or female condom)
- •d. Male sterilization at least 6 months prior to the screening, should be the sole male partner for that subject) plus one additional contraception method (hormonal or barrier method)
- •e. Documented tubal sterilization (tubal ligation or transcervical tubal occlusion with documentation of occlusion 6 months post-procedure)
- •f. Total abstinence, partial abstinence is not acceptable (no sexual intercourse or genital contact with a male partner)
- •12. Female subjects of non-child bearing potential or female subjects who have completed menopause are defined as subjects who have 12 consecutive months of spontaneous amenorrhea (not amenorrhea induced by a medical condition or medical therapy) or have bilateral absence of the ovaries. Female subjects of non-child bearing potential are not required to use effective method of contraception during the study
- •13. No history of addiction to any recreational drug or drug dependence or alcohol addiction
排除标准
- •Female subjects will be excluded from the study based on the following criteria:
- •1.Known hypersensitivity to Paclitaxel or the components of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin--bound) or to any of the related drugs (other taxane products).
- •2.History or presence of any uncontrolled systemic disease (e.g. cardiovascular disease, hypertension, diabetes mellitus etc.).
- •3.Subjects taking any of the inhibitors or inducers of either CYP2C8 or CYP3A4. (Appendix C)
- •4.Known CNS metastasis.
- •5.Major surgical procedure (including periodontal) within 28 days of first dose of Investigational Product.
- •6.Surgical or other non-healing wounds.
- •7.Subjects with positive serology for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- •8.Subjects with current clinical or laboratory evidence of active infection.
- •9.History of other malignancies in the last 5 years (except in situ cancer or basal or squamous cell skin cancer).
- •10.Has not recovered to Grade 0 or 1 toxicity from previous anticancer treatments or previous investigational agents. Exceptions are alopecia (any grade is acceptable), fatigue (Grade less than or equal to is acceptable), and peripheral neuropathy (stable Grade 2 is acceptable) (Per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], V5.0).
- •11.Participation in any clinical study within 90 days before the first dose of Investigational Product.
- •12.Loss of greater or equal to 350mL (1 unit) of blood within 90 days of enrollment in the study.
- •13.Any other medical condition or serious intercurrent illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness/social situations that would limit adherence to study requirements.
- •14.Subjects who are breastfeeding and lactating.
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