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

Recurrent or Metastatic Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03109249
• Other study ID #: CLR_16_13
• Status: Completed
• Phase: Phase 1
• Start date: January 14, 2017
• Est. completion date: October 4, 2018

Study information

• Verified date: May 2019
• Source: Sun Pharma Advanced Research Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: October 4, 2018
• Est. primary completion date: October 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Recurrent or Metastatic Breast Cancer

Intervention

Drug:
• SPARC1613
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
• Reference1613
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)

Locations

Country	Name	City	State
India	SPARC Site 20	Ahmedabad	Gujarat
India	SPARC site 39	Ahmedabad	Gujarat
India	SPARC Site 23	Aurangabad	Maharashtra
India	SPARC Site 25	Aurangabad	Maharashtra
India	SPARC Site 9	Aurangabad	Marashtra
India	SPARC Site 13	Bangalore	Karnataka
India	SPARC Site 28	Bangalore	Karnataka
India	SPARC site 41	Bangalore	Karnataka
India	SPARC Site 22	Belgaum	Karnataka
India	SPARC site 42	Chennai	Tamil Nadu
India	SPARC site 38	Karamsad	Gujarat
India	SPARC Site 15	Khorda	Orissa
India	SPARC Site 32	Madurai	Tamil Nadu
India	SPARC Site 7	Mangalore	Karnataka
India	SPARC Site 2	Mumbai	Maharashtra
India	SPARC Site 12	Nagpur	Maharashtra
India	SPARC site 34	Nashik	Maharashtra
India	SPARC Site 37	Nashik	Maharashtra
India	SPARC Site 18	Pune	Maharashtra
India	SPARC Site 4	Pune	Maharashtra
India	SPARC Site 27	Surat	Gujarat
India	SPARC Site 35	Surat	Gujarat
India	SPARC Site 24	Vadodara	Gujarat
India	SPARC Site 40	Visakhapatnam	Andhra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03	First dose of trial drug to one month after last dose.
Primary	Maximum observed concentration (Cmax)		Pre-dose,post dose upto 3 days