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

Sun Pharma Advanced Research (SPARC)

Status and phase: Terminated; Phase 1

Conditions: Breast Cancer

Treatments: Drug: Reference1210; Drug: SPARC1210

Study type: Interventional

Funder types: Industry

Identifiers

NCT02136927

CLR_12_10

Details and patient eligibility

About

Pharmacokinetic, bioequivalence study

Enrollment: 33 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

33 participants in 2 patient groups

SPARC1210

Experimental group

Description:

Intravenous administration of SPARC1210

Treatment:

Drug: SPARC1210

Reference1210

Active Comparator group

Description:

Intravenous administration of Reference1210

Treatment:

Drug: Reference1210