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.

Overview

No summary available.

Registry

who.int

Start Date

TBD

End Date

September 29, 2010

Last Updated

4 years ago

Study Type

Interventional

Sponsor

•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;

•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;