CTRI/2011/11/002124已完成1 期
A phase 1 pharmacokinetic, safety, and tolerability study of paclitaxel injection concentrate for nano-dispersion (PICN) administered once a week in subjects with advanced solid malignancies in Indian population.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 21
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
- •1. Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage for
- •which taxane-based therapy is a rational treatment option;
- •2. Age more than or equal to 18 years;
- •3. ECOG performance status less than or equal to 2;
- •4. Estimated life expectancy of at least 12-weeks;
- •5. Measurable disease as per RECIST guideline (Version 1.1);
- •6. Adequate organ and immune system function as indicated by the following laboratory
- •values, obtained less than or equal to 2 weeks prior to dosing:
- •7. Any chemotherapy (except palliative bisphosphate therapy for bone pain), 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;
- •8. If subject has received taxanes, he/she must not have relapsed with cancer within 48-weeks
- •of completing taxane therapy;
- •9. Women of child bearing potential practicing an acceptable method of birth control as judged
- •by the investigator(s) [such as condoms, foams, jellies, diaphragm, intrauterine device
- •(IUD), oral or log acting injected contraceptives] from atleast 2 months prior to study entry and through the duration of the study; or postmenopausal for at least 1 year, surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy has been performed on the subject); with a negative urine pregnancy test; if male, subject must practice adequate contraception;
- •10. Willing to participate and give written informed consent.
排除标准
- •Known hypersensitivity to the study drug;
- •Treatment with any investigational agents within 30-days of study entry;
- •Presence of clinically evident active CNS metastases, including leptomeningial involvement,
- •requiring steroid or radiation therapy;
- •Pre-existing peripheral neuropathy (grade 1 or higher â?? as per CTCAE, Version 4.02);
- •Any other severe concurrent disease which in the judgment of the investigator would make
- •the subject inappropriate for entry into this study;
- •Presence of clinically significant pleural/ascitic fluid (Fluid should be tapped before dosing).
- •Tests for exclusion: Serum Pregnancy Test (If applicable), Human immunodeficiency virus
- •antibodies I/II (HIV-I/II Ab), Hepatitis B surface antigen (HBs-Ag), Hepatitis C virus
- •antibodies (HCV-Ab).
研究者
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