CTRI/2009/091/000441已完成1 期
An open label, balanced, randomized, two period, two treatment, two sequence, and two way crossover study to evaluate safety and pharmacokinetic comparison of intravenous infusion of paclitaxel Lipid Suspension and Taxol® in patients with Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
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
- •Female & > or =18 years and < 65 years of age and having a body mass index (BMI) at least 17 calculated as weight in kg/(height in meter)2 with histopathologically/cytologically confirmed metastatic breast cancer, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2, adequate bone marrow, renal and hepatic functions, recovery from any toxic effects incurred from previous chemotherapy as judged by the investiagator and with life expectancy of at least 3 months.
- •-The patient must have given written, personally signed and dated, informed consent to participate in the study before initiating any study related procedures.
- •-For patient with child bearing potential: Patient should not be pregnant or nursing, having negative pregnancy test at screening, and must be using effective form of birth control measure during and for 1 month after study participation.
排除标准
- •-History of hypersensitivity to paclitaxel injection or other drugs containing polyoxyethylated castor oil. Like cyclosporine or teniposide
- •-Any cardiac conditions
- •-History of drug addiction within last 1 year
- •-History of brain metastasis
- •-Preexisting motor or sensory neurotoxicity of severity > or = grade 2 as defined by NCI criteria
- •-Serum bilirubin > 2 times ULN, or if SGOT and/or SGPT > 2 times ULN
- •-The neutrophil count < 1,500 cells/mm3 and platelet count < 100,000 cells/mm3
- •-HIV infection
- •-Any other condition that in investigators judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study
- •-Donation of blood (1 unit of 350 ml) within 90 days prior to receiving the first dose of study medicine
- •-Known existing uncontrolled coagulopathy
研究者
相似试验
尚未招募
不适用
To estimate the bioavailability of diosmin in FLAVOSPRINT 500 PRO versus FLAVOSPRINT in healthy adult human subjects.CTRI/2017/07/008952GIELLEPI
已完成
不适用
A clinical trial to study the pharmacokinetic comparision of two formulations of Docetaxel injections in Advanced Solid Tumor PatientsCTRI/2009/091/000316Intas Pharmaceuticals Limited India32
已完成
不适用
An Open label, balanced, randomized, two-period, two-treatment, two-sequence, single oral dose, crossover Bioequivalence study of RIFAIZO PE in healthy adult human subjects under fasting conditionsCTRI/2022/03/041028Swiss Parenterals Ltd31
已完成
不适用
A randomized, open label balanced two period, two-treatment, two-sequence crossover study to evaluate the effect of food on the pharmacokinetics of sildenafil after a single oral administration of Lybrido in healthy female subjectsSexual dysfunctionproblems with sexual functioning10040480NL-OMON41076EB FlevoResearch BV18
已完成
不适用
ybrido Food effect studyVoedsel effect onderzoek naar LybridoNL-OMON25592EB FSD18