Clinical trial NCT03109249: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Recurrent or Metastatic Breast Cancer
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Pre-dose,post dose upto 3 days
Secondary outcomes:
Other outcomes:
measure: Adverse events
timeFrame: First dose of trial drug to one month after last dose.
Locations:
city: Visakhapatnam
country: India
facility: SPARC Site 40
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: SPARC Site 20
state: Gujarat
city: Ahmedabad
country: India
facility: SPARC site 39
state: Gujarat
city: Karamsad
country: India
facility: SPARC site 38
state: Gujarat
city: Surat
country: India
facility: SPARC Site 27
state: Gujarat
city: Surat
country: India
facility: SPARC Site 35
state: Gujarat
city: Vadodara
country: India
facility: SPARC Site 24
state: Gujarat
city: Bangalore
country: India
facility: SPARC Site 13
state: Karnataka
city: Bangalore
country: India
facility: SPARC site 41
state: Karnataka
city: Bangalore
country: India
facility: SPARC Site 28
state: Karnataka
city: Belgaum
country: India
facility: SPARC Site 22
state: Karnataka
city: Mangalore
country: India
facility: SPARC Site 7
state: Karnataka
city: Aurangabad
country: India
facility: SPARC Site 25
state: Maharashtra
city: Aurangabad
country: India
facility: SPARC Site 23
state: Maharashtra
city: Mumbai
country: India
facility: SPARC Site 2
state: Maharashtra
city: Nagpur
country: India
facility: SPARC Site 12
state: Maharashtra
city: Nashik
country: India
facility: SPARC site 34
state: Maharashtra
city: Nashik
country: India
facility: SPARC Site 37
state: Maharashtra
city: Pune
country: India
facility: SPARC Site 18
state: Maharashtra
city: Pune
country: India
facility: SPARC Site 4
state: Maharashtra
city: Aurangabad
country: India
facility: SPARC Site 9
state: Marashtra
city: Khorda
country: India
facility: SPARC Site 15
state: Orissa
city: Chennai
country: India
facility: SPARC site 42
state: Tamil Nadu
city: Madurai
country: India
facility: SPARC Site 32
state: Tamil Nadu
Study officials:
References: