Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Pharmacokinetic, bioequivalence study

• 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 entire study.

• Histologically or cytologically confirmed diagnosis of breast cancer;

• Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;

• Age 18 years or more

Exclusion Criteria:

• Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);

• Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;

• Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);

• Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study