Spots Global Cancer Trial Database for Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer
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Trial Identification
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 ID: NCT03109249
Conditions
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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
SPARC Site 40, Visakhapatnam, Andhra Pradesh, India
SPARC Site 20, Ahmedabad, Gujarat, India
SPARC site 39, Ahmedabad, Gujarat, India
SPARC site 38, Karamsad, Gujarat, India
SPARC Site 27, Surat, Gujarat, India
SPARC Site 35, Surat, Gujarat, India
SPARC Site 24, Vadodara, Gujarat, India
SPARC Site 13, Bangalore, Karnataka, India
SPARC site 41, Bangalore, Karnataka, India
SPARC Site 28, Bangalore, Karnataka, India
SPARC Site 22, Belgaum, Karnataka, India
SPARC Site 7, Mangalore, Karnataka, India
SPARC Site 25, Aurangabad, Maharashtra, India
SPARC Site 23, Aurangabad, Maharashtra, 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 9, Aurangabad, Marashtra, India
SPARC Site 15, Khorda, Orissa, India
SPARC site 42, Chennai, Tamil Nadu, India
SPARC Site 32, Madurai, Tamil Nadu, India
Contact Details
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