A Randomized, Open Label,Two Period, Single Dose Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Patients with Breast Cancer
Phase 1
- Conditions
- Health Condition 1: null- Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment optionHealth Condition 2: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2014/04/004528
- Lead Sponsor
- Sun Pharma Advanced Research Company Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 72
Inclusion Criteria
The subject has given written informed consent.
-Histologically or cytologically confirmed diagnosis of breast cancer;
-Locally recurrent or metastatic breast cancer; Age 18 to 65 years, inclusive;
-ECOG Performance Status less than or eual to 1;
Exclusion Criteria
-Known hypersensitivity to both the study drugs or their excipients;
-Presence of clinically symptomatic active CNS metastases;
-Pre-existing clinically significant peripheral neuropathy;
-Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic (PK) profiles of PICN and AbraxaneTimepoint: Pharmacokinetic (PK) samples will be collected on Day 1 & 2 of Cycle 1 & 2
- Secondary Outcome Measures
Name Time Method Safety of PICN and AbraxaneTimepoint: Safety information will be collected during subject visits on Day 1, 8, 15 of Cycle 1 & 2 and end-of-study.