To Assess the Bioavailability and Safety of Paclitaxel Injection Concentrate for Suspension in Subjects With Locally Recurrent or Metastatic Breast Cancer

Summary

A randomized, multi center, open label, two-period, single dose, crossover study to evaluate the bioavailability and safety of Paclitaxel Injection Concentrate for Suspension in Locally Recurrent or Metastatic Breast Cancer subjects.

Timeline

Start

2020-04-27

Primary completion

2021-01-28

Completion

2021-01-28

Outcome

Outcome not reported

Stopped: “After meeting with the FDA, SPARC concludes a BE study will not be required”

Drugs

Indications