Neoplasms

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Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

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Disease Attributes

Intravenous administration of Reference1613

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

SPARC1613

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

Reference1613

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.

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

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

Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer	NCT03109249	Recurrent or Me...	SPARC1613 Reference1613	18 Years -	Sun Pharma Advanced Research Company Limited
Pharmacokinetic Study of SPARC1613 and reference1613 in Subjects With Locally Recurrent or Metastatic Breast Cancer	NCT03109249	Recurrent or Me...	SPARC1613 Reference1613	18 Years -	Sun Pharma Advanced Research Company Limited

Spots Global Cancer Trial Database for sparc1613

Every month we try and update this database with for sparc1613 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sparc1613

Every month we try and update this database with for sparc1613 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sparc1613 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.