Overview

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