Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer

Phase 1

Completed

• Conditions: Recurrent or Metastatic Breast Cancer
• Interventions: Drug: Reference1613; Drug: SPARC1613

• Registration Number: NCT03109249
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

SPARC1613 is chemotherapeutic agent with a wide spectrum of anti-tumor activity. It is used extensively in the treatment of advanced carcinomas of the breast, ovaries, lung, and other solid tumors.This is pharmacokinetic study of SPARC1613 and Reference1613.

Detailed Description

The purpose of this study is to evaluate level of test medication with respect to time in the body, and safety when compared with the reference medication Subject will be randomly assigned to receive an intravenous infusion of either SPARC1613 delivered over 25 (±1) minutes or Reference1613 delivered over 30 (±1) minutes

Study Timeline

• Study Start: 2017-01-14
• Study First Submitted: 2017-04-06
• Study First Submitted QC: 2017-04-06
• Study First Posted: 2017-04-12
• Primary Completion: 2018-10-04
• Study Completion: 2018-10-04
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-02
• Last Update Posted: 2019-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 142

Inclusion Criteria

• The subject has given written, informed consent and is available for the duration of study
• Histologically or cytologically confirmed diagnosis of breast cancer
• Male or female aged ≥ 18 years
• Females subjects of child-bearing potential must have a negative urine pregnancy test
• Female subjects must be non-lactating and non-breastfeeding
• Subject must be willing and able to comply with scheduled visits, treatment plan and laboratory testing

Exclusion Criteria

• Known hypersensitivity to either of the study drugs or their excipients
• Inability to undergo venipuncture and/or tolerate venous access
• Pre-existing clinically significant peripheral neuropathy
• Positive laboratory exclusion test (HIV, HBsAg, or HCV)
• Treatment with investigational agents or participation in clinical trial within 30 days of study entry

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SPARC1613	Reference1613	Intravenous administration of SPARC1613
Reference 1613	SPARC1613	Intravenous administration of Reference1613

Primary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Pre-dose,post dose upto 3 days

Trial Locations

Locations (24)

SPARC Site 4; 🇮🇳 Pune, Maharashtra, India

SPARC Site 15; 🇮🇳 Khorda, Orissa, India

SPARC Site 9; 🇮🇳 Aurangabad, Marashtra, India

SPARC Site 32; 🇮🇳 Madurai, Tamil Nadu, India

SPARC Site 40; 🇮🇳 Visakhapatnam, Andhra Pradesh, India

SPARC Site 24; 🇮🇳 Vadodara, Gujarat, India

SPARC Site 13; 🇮🇳 Bangalore, Karnataka, India

SPARC Site 22; 🇮🇳 Belgaum, Karnataka, India

SPARC Site 23; 🇮🇳 Aurangabad, Maharashtra, India

SPARC Site 20; 🇮🇳 Ahmedabad, Gujarat, India

SPARC site 39; 🇮🇳 Ahmedabad, Gujarat, India

SPARC Site 18; 🇮🇳 Pune, Maharashtra, India

SPARC site 38; 🇮🇳 Karamsad, Gujarat, India

SPARC Site 35; 🇮🇳 Surat, Gujarat, India

SPARC Site 2; 🇮🇳 Mumbai, Maharashtra, India

SPARC Site 7; 🇮🇳 Mangalore, Karnataka, India

SPARC Site 27; 🇮🇳 Surat, Gujarat, India

SPARC site 41; 🇮🇳 Bangalore, Karnataka, India

SPARC Site 28; 🇮🇳 Bangalore, Karnataka, India

SPARC Site 12; 🇮🇳 Nagpur, Maharashtra, India

SPARC site 42; 🇮🇳 Chennai, Tamil Nadu, India

SPARC site 34; 🇮🇳 Nashik, Maharashtra, India

SPARC Site 37; 🇮🇳 Nashik, Maharashtra, India

SPARC Site 25; 🇮🇳 Aurangabad, Maharashtra, India