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

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.

Study Overview

• Status: Completed
• Conditions: Recurrent or Metastatic Breast Cancer
• Intervention / Treatment: Drug: Reference1613; Drug: SPARC1613

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 Type: Interventional
• Enrollment (Actual): 142
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Visakhapatnam, Andhra Pradesh, India, 530017
      • SPARC Site 40
  • Gujarat
    • Ahmedabad, Gujarat, India, 380052
      • SPARC Site 20
    • Ahmedabad, Gujarat, India, 380060
      • SPARC site 39
    • Karamsad, Gujarat, India, 388325
      • SPARC site 38
    • Surat, Gujarat, India, 395002
      • SPARC Site 27
    • Surat, Gujarat, India, 422005
      • SPARC Site 35
    • Vadodara, Gujarat, India, 391760
      • SPARC Site 24
  • Karnataka
    • Bangalore, Karnataka, India, 560027
      • SPARC Site 13
    • Bangalore, Karnataka, India, 560072
      • SPARC Site 41
    • Bangalore, Karnataka, India, 560090
      • SPARC Site 28
    • Belgaum, Karnataka, India, 590010
      • SPARC Site 22
    • Mangalore, Karnataka, India, 5750001
      • SPARC Site 7
  • Maharashtra
    • Aurangabad, Maharashtra, India, 431 003
      • SPARC Site 25
    • Aurangabad, Maharashtra, India, 431210
      • SPARC Site 23
    • Mumbai, Maharashtra, India, 400022
      • SPARC Site 2
    • Nagpur, Maharashtra, India, 440003
      • SPARC Site 12
    • Nashik, Maharashtra, India, 422004
      • SPARC Site 34
    • Nashik, Maharashtra, India, 422005
      • SPARC Site 37
    • Pune, Maharashtra, India, 411 044
      • SPARC Site 18
    • Pune, Maharashtra, India, 411004
      • SPARC Site 4
  • Marashtra
    • Aurangabad, Marashtra, India, 431005
      • SPARC Site 9
  • Orissa
    • Khorda, Orissa, India, 751007
      • SPARC Site 15
  • Tamil Nadu
    • Chennai, Tamil Nadu, India, DrGRaja
      • SPARC Site 42
    • Madurai, Tamil Nadu, India, 625107
      • SPARC Site 32

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SPARC1613; Intravenous administration of SPARC1613	Drug: Reference1613; Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
Active Comparator: Reference 1613; Intravenous administration of Reference1613	Drug: SPARC1613; Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum observed concentration (Cmax)	Pre-dose,post dose upto 3 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Sun Pharma Advanced Research Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2017
• Primary Completion (Actual): October 4, 2018
• Study Completion (Actual): October 4, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 6, 2017
• First Posted (Actual): April 12, 2017

Study Record Updates

• Last Update Posted (Actual): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 2, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Neoplasms; Neoplasms by Site; Disease Attributes; Breast Diseases; Breast Neoplasms; Recurrence
• Other Study ID Numbers: CLR_16_13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No