Overview

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