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

Primary Purpose

Recurrent or Metastatic Breast Cancer

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
SPARC1613
Reference1613
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent or Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SPARC Site 40
  • SPARC Site 20
  • SPARC site 39
  • SPARC site 38
  • SPARC Site 27
  • SPARC Site 35
  • SPARC Site 24
  • SPARC Site 13
  • SPARC site 41
  • SPARC Site 28
  • SPARC Site 22
  • SPARC Site 7
  • SPARC Site 25
  • SPARC Site 23
  • SPARC Site 2
  • SPARC Site 12
  • SPARC site 34
  • SPARC Site 37
  • SPARC Site 18
  • SPARC Site 4
  • SPARC Site 9
  • SPARC Site 15
  • SPARC site 42
  • SPARC Site 32

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SPARC1613

Reference 1613

Arm Description

Intravenous administration of SPARC1613

Intravenous administration of Reference1613

Outcomes

Primary Outcome Measures

Maximum observed concentration (Cmax)

Secondary Outcome Measures

Full Information

First Posted
April 6, 2017
Last Updated
May 2, 2019
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT03109249
Brief Title
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
Official Title
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
January 14, 2017 (Actual)
Primary Completion Date
October 4, 2018 (Actual)
Study Completion Date
October 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent or Metastatic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC1613
Arm Type
Experimental
Arm Description
Intravenous administration of SPARC1613
Arm Title
Reference 1613
Arm Type
Active Comparator
Arm Description
Intravenous administration of Reference1613
Intervention Type
Drug
Intervention Name(s)
SPARC1613
Intervention Description
Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
Intervention Type
Drug
Intervention Name(s)
Reference1613
Intervention Description
Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
Primary Outcome Measure Information:
Title
Maximum observed concentration (Cmax)
Time Frame
Pre-dose,post dose upto 3 days
Other Pre-specified Outcome Measures:
Title
Adverse events
Description
Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03
Time Frame
First dose of trial drug to one month after last dose.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SPARC Site 40
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530017
Country
India
Facility Name
SPARC Site 20
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380052
Country
India
Facility Name
SPARC site 39
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380060
Country
India
Facility Name
SPARC site 38
City
Karamsad
State/Province
Gujarat
ZIP/Postal Code
388325
Country
India
Facility Name
SPARC Site 27
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
SPARC Site 35
City
Surat
State/Province
Gujarat
ZIP/Postal Code
422005
Country
India
Facility Name
SPARC Site 24
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
391760
Country
India
Facility Name
SPARC Site 13
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
SPARC site 41
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560072
Country
India
Facility Name
SPARC Site 28
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560090
Country
India
Facility Name
SPARC Site 22
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
SPARC Site 7
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
5750001
Country
India
Facility Name
SPARC Site 25
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431 003
Country
India
Facility Name
SPARC Site 23
City
Aurangabad
State/Province
Maharashtra
ZIP/Postal Code
431210
Country
India
Facility Name
SPARC Site 2
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400022
Country
India
Facility Name
SPARC Site 12
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440003
Country
India
Facility Name
SPARC site 34
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422004
Country
India
Facility Name
SPARC Site 37
City
Nashik
State/Province
Maharashtra
ZIP/Postal Code
422005
Country
India
Facility Name
SPARC Site 18
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411 044
Country
India
Facility Name
SPARC Site 4
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
SPARC Site 9
City
Aurangabad
State/Province
Marashtra
ZIP/Postal Code
431005
Country
India
Facility Name
SPARC Site 15
City
Khorda
State/Province
Orissa
ZIP/Postal Code
751007
Country
India
Facility Name
SPARC site 42
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
DrGRaja
Country
India
Facility Name
SPARC Site 32
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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

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