NCT03109249 - Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer | Biotech Hunter

Enrollment

142

Participants

Timeline

Start Date

January 14, 2017

Primary Completion Date

October 4, 2018

Study Completion Date

October 4, 2018

Conditions

Recurrent or Metastatic Breast Cancer

Interventions

DRUG

SPARC1613

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

DRUG

Reference1613

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

Trial Locations (24)

380052

SPARC Site 20, Ahmedabad

380060

SPARC site 39, Ahmedabad

388325

SPARC site 38, Karamsad

391760

SPARC Site 24, Vadodara

395002

SPARC Site 27, Surat

400022

SPARC Site 2, Mumbai

411004

SPARC Site 4, Pune

422004

SPARC site 34, Nashik

422005

SPARC Site 35, Surat

SPARC Site 37, Nashik

431005

SPARC Site 9, Aurangabad

431210

SPARC Site 23, Aurangabad

440003

SPARC Site 12, Nagpur

530017

SPARC Site 40, Visakhapatnam

560027

SPARC Site 13, Bangalore

560072

SPARC site 41, Bangalore

560090

SPARC Site 28, Bangalore

590010

SPARC Site 22, Belagavi

625107

SPARC Site 32, Madurai

751007

SPARC Site 15, Khordha

5750001

SPARC Site 7, Mangalore

431 003

SPARC Site 25, Aurangabad

411 044

SPARC Site 18, Pune

DrGRaja

SPARC site 42, Chennai

All Listed Sponsors

lead

Sun Pharma Advanced Research Company Limited

INDUSTRY