Skip to main content
OpenTrials
Completed

NCT Number: NCT03109249

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Recurrent or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SPARC Site 40, Visakhapatnam, Andhra Pradesh, India

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1613

Drug

Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)

Reference1613

Drug

Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Pre-dose,post dose upto 3 days

Other outcomes

  1. Adverse events

    Time frame: First dose of trial drug to one month after last dose.

    Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2017
Registry last updated
May 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.