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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03109249

Enrollment

142

Registered

2017-04-12

Start date

2017-01-14

Completion date

2018-10-04

Last updated

2019-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Recurrent or Metastatic Breast Cancer

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

Interventions

DRUGSPARC1613

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

DRUGReference1613

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Other

Measure	Time frame	Description
Adverse events	First dose of trial drug to one month after last dose.	Adverse events encountered following dosing with SPARC1613 and Reference1613 will be recorded as per CTCAE4.03

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026