drugset / Trial / NCT03109249

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

NCT03109249 ↗

Phase 1 Completed 142 enrolled Sun Pharma Advanced Research Company Limited
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2017-01-14
Primary completion
2018-10-04
Completion
2018-10-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Reference1613 Unknown 260 mg/m2 Intravenous
Comparator SPARC1613 Unknown 260 mg/m2 Intravenous

Indications