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

Sun Pharma Advanced Research (SPARC)

Status and phase

Completed

Phase 1

Conditions

Recurrent or Metastatic Breast Cancer

Treatments

Drug: SPARC1613

Drug: Reference1613

Study type

Interventional

Funder types

Industry

Identifiers

NCT03109249

CLR_16_13

Details and patient eligibility

About

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.

Full description

The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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