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

Sun Pharma Advanced Research (SPARC) logo

Sun Pharma Advanced Research (SPARC)

Status and phase

Completed
Phase 1

Conditions

Recurrent or Metastatic Breast Cancer

Treatments

Drug: SPARC1613
Drug: Reference1613

Study type

Interventional

Funder types

Industry

Identifiers

NCT03109249
CLR_16_13

Details and patient eligibility

About

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.

Full 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

Enrollment

142 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

142 participants in 2 patient groups

SPARC1613
Experimental group
Description:
Intravenous administration of SPARC1613
Treatment:
Drug: Reference1613
Reference 1613
Active Comparator group
Description:
Intravenous administration of Reference1613
Treatment:
Drug: SPARC1613

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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