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

Phase 1

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: SPARC1210; Drug: Reference1210

• Registration Number: NCT02136927
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

Pharmacokinetic, bioequivalence study

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-09
• Study First Submitted QC: 2014-05-09
• Study First Posted: 2014-05-13
• Study Start: 2014-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPARC1210	SPARC1210	Intravenous administration of SPARC1210
Reference1210	Reference1210	Intravenous administration of Reference1210

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Pre-dose, post-dose up to 3 days	Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.

Trial Locations

Locations (12)

SPARC Site 9; 🇮🇳 Hyderabad, Andhra Pradesh, India

SPARC Site 8; 🇮🇳 Cochin, Kerala, India

SPARC Site 12; 🇮🇳 Hyderabad, Andhra Pradesh, India

SPARC Site 1; 🇮🇳 Pune, Maharashtra, India

SPARC Site 2; 🇮🇳 Goraj, Gujarat, India

SPARC Site 5; 🇮🇳 Nagpur, Maharashtra, India

SPARC Site 4; 🇮🇳 Nashik, Maharashtra, India

SPARC Site 3; 🇮🇳 Pune, Maharashtra, India

SPARC Site 11; 🇮🇳 Mumbai, Maharashtra, India

SPARC Site 7; 🇮🇳 Madurai, Tamil Nadu, India

SPARC Site 10; 🇮🇳 Chennai, Tamil Nadu, India

SPARC Site 6; 🇮🇳 New Delhi, Delhi, India