CTRI/2009/091/000262已完成1 期
Phase 1 safety, efficacy, and pharmacokinetic study of Paclitaxel nano-dispersion injection in subjects with metastatic breast cancer: A randomized, open label, dose-ranging, active controlled, comparative, parallel group, and multi-centric study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Histologically or cytologically confirmed diagnosis of breast cancer after failure of combination chemotherapy for metastatic disease.
- •Female subjects with age 18 to 75-years inclusive;
- •Performance status <= 2 on the ECOG performance scale
- •Must have estimated life expectancy of at least 12-weeks;
- •Measurable or evaluable disease as per RECIST criteria;
- •Must have adequate organ and immune system function as indicated by the following laboratory values, obtained <= 2 weeks prior to enrollment:
- •ANC >= 1.5 Ã? 109 /L; Hb >= 9.0 g/dL; Platelets>= 100 Ã? 109 /L; Sr Creatinine: <= 2.0 mg/dL; Total Bilirubin<= 1.5 mg/dL or <= 2 mg/dL (for liver mets); AST & ALT<= 2.5 Ã? ULN or <= 5 Ã? ULN (for liver mets) Alkaline phosphatase<= 5 Ã? ULN (unless bone mets are present in the absense of liver mets); Serum Calcium WNL
- •Any chemotherapy (except taxanes), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities incurred as a result of previous therapy;
- •Prior chemotherapy containing taxanes must have been completed at least 48-weeks before enrollment in this study;
- •If subject has received taxanes as adjuvant therapy, she must not have relapsed with breast cancer within 48-weeks of completing adjuvant taxane therapy;
- •Prior hormonal therapy for breast cancer must have been completed at least 2-weeks before enrollment in this study;
- •Female subjects with childbearing potential must have negative serum pregnancy test within last 7-days of study enrollment. Women of reproductive potential must use an effective contraceptive method while enrolled in the study;
- •Willing to participate and give written informed consent.
排除标准
- •Uncontrolled angina, subjects with a history of myocardial infarction within 2-months of enrollment, or subjects with cardiac functional capacity Class III or IV as defined by NYHA classification;
- •Known hypersensitivity to study drugs or its excipients or analogs;
- •Treatment with any investigational agents within 30-days of study entry;
- •Active and uncontrolled infection;
- •Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow-up;
- •Presence of clinically apparent CNS metastases or carcinomatous meningitis;
- •Subjects with diabetes mellitus;
- •Pre-existing peripheral neuropathy (grade 1 or higher â?? as per CTCAE);
- •Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;
- •HIV positive or who have an AIDS-related illness;
- •Prior radiation therapy to >=25% of the bone marrow (e.g. whole pelvic radiation is allowed). Subjects must have recovered from the acute side effects of radiotherapy;
- •Prior bone marrow/stem cell transplantation.
研究者
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