A Phase 1, Open Label, Dose-Ranging Pharmacokinetic, Safety, and Efficacy Studyof Paclitaxel Injection Concentrate for Nano-Dispersion (PICN) Administered EveryThree Weeks In Subjects with Solid Tumors and With or Without HepaticImpairment.

Sun Pharma Advanced Research Company Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1. The subject has given written, informed consent and is available for the entire study;
•2. Histologically or cytologically confirmed diagnosis of solid tumor in advanced stage for which taxane-based therapy is a rational treatment option;
•3. Documented normal hepatic function or hepatic impairment of: bilirubin > upper limit of normal
•(ULN) to <= 1.25 x ULN and AST > ULN to < 10 x ULN; bilirubin 1.26 to 2.0 x ULN and AST >
•ULN to < 10 x ULN; and bilirubin 2.01 to 5.0 x ULN and AST > ULN to < 10 x ULN.
•4. Age 18 to 65 years, inclusive;
•5. ECOG Performance Status <= 2;
•6. Estimated life expectancy of at least 12-weeks;
•7. Measurable disease according to RECIST v1.1 guideline;

•1. Known hypersensitivity to both the study drugs or their excipients (Cholesteryl sulfate, Caprylic
•acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
•2. Presence of clinically symptomatic active CNS metastases, including leptomeningial involvement,
•requiring steroid or radiation therapy;
•3. Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE,
•Version 4.0);
•4. Any other severe concurrent disease which in the judgment of the investigator would make the
•subject inappropriate for entry into this study;

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