Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2018-10-04
• Target enrollment: 0
• Participant gender: All

Summary

SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Criteria

Inclusion Criteria:

• The subject has given written, informed consent and is available for the duration of study

• Histologically or cytologically confirmed diagnosis of breast cancer

• Male or female aged ≥ 18 years

• Females subjects of child-bearing potential must have a negative urine pregnancy test

• Female subjects must be non-lactating and non-breastfeeding

• Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing

Exclusion Criteria:

• Known hypersensitivity to either of the study drugs or their excipients

• Inability to undergo venipuncture and/or tolerate venous access

• Pre-existing clinically significant peripheral neuropathy

• Positive laboratory exclusion test (HIV, HBsAg, or HCV)

• Treatment with investigational agents or participation in clinical trial within 30 days of study entry