Pharmacokinetic study of SPARC1613 and Reference1613
Not Applicable
Completed
- Conditions
- Health Condition 1: null- Metastatic breast cancer
- Registration Number
- CTRI/2016/12/007565
- Lead Sponsor
- Sun Pharma Advanced Research Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 142
Inclusion Criteria
1. The subject has given written, informed consent (or legally acceptable representative /impartial
witness when applicable) and is available for the duration of study
2. Histologically or cytologically confirmed diagnosis of breast cancer
3. Estimated life expectancy of at least 12 weeks
4. ECOG performance status less than 1
Exclusion Criteria
1. Known hypersensitivity to either of the study drugs or their excipients
2. Inability to undergo venipuncture and/or tolerate venous access
3. Presence of clinically symptomatic active CNS metastases, including leptomeningial
involvement, requiring steroid or radiation therapy
4. Pre-existing clinically significant peripheral neuropathy
Study & Design
- Study Type
- BA/BE
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter Cmax, and AUCTimepoint: Pharmacokinetic parameter Cmax, and AUC
- Secondary Outcome Measures
Name Time Method oneTimepoint: None