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

NCT03109249 | Completed Phase 1 FDA Drug

• 1 other identifier: CLR_16_13
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 24

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.

Conditions

Recurrent or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum observed concentration (Cmax)

  Pre-dose,post dose upto 3 days

Other Outcomes (1)

• Adverse events

  First dose of trial drug to one month after last dose.

Study Arms (2)

SPARC1613

EXPERIMENTAL

Intravenous administration of SPARC1613

Drug: Reference1613

Reference 1613

ACTIVE COMPARATOR

Intravenous administration of Reference1613

Drug: SPARC1613

Interventions

SPARC1613 DRUG

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

Reference 1613

Reference1613 DRUG

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

SPARC1613

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Treatment with investigational agents or participation in clinical trial within 30 days of study entry

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (24)

SPARC Site 40

Visakhapatnam, Andhra Pradesh, 530017, India

Location

SPARC Site 20

Ahmedabad, Gujarat, 380052, India

Location

SPARC site 39

Ahmedabad, Gujarat, 380060, India

Location

SPARC site 38

Karamsad, Gujarat, 388325, India

Location

SPARC Site 27

Surat, Gujarat, 395002, India

Location

SPARC Site 35

Surat, Gujarat, 422005, India

Location

SPARC Site 24

Vadodara, Gujarat, 391760, India

Location

SPARC Site 13

Bangalore, Karnataka, 560027, India

Location

SPARC site 41

Bangalore, Karnataka, 560072, India

Location

SPARC Site 28

Bangalore, Karnataka, 560090, India

Location

SPARC Site 22

Belagavi, Karnataka, 590010, India

Location

SPARC Site 7

Mangalore, Karnataka, 5750001, India

Location

SPARC Site 25

Aurangabad, Maharashtra, 431 003, India

Location

SPARC Site 23

Aurangabad, Maharashtra, 431210, India

Location

SPARC Site 2

Mumbai, Maharashtra, 400022, India

Location

SPARC Site 12

Nagpur, Maharashtra, 440003, India

Location

SPARC site 34

Nashik, Maharashtra, 422004, India

Location

SPARC Site 37

Nashik, Maharashtra, 422005, India

Location

SPARC Site 18

Pune, Maharashtra, 411 044, India

Location

SPARC Site 4

Pune, Maharashtra, 411004, India

Location

SPARC Site 9

Aurangabad, Marashtra, 431005, India

Location

SPARC Site 15

Khordha, Odisha, 751007, India

Location

SPARC site 42

Chennai, Tamil Nadu, DrGRaja, India

Location

SPARC Site 32

Madurai, Tamil Nadu, 625107, India

Location

MeSH Terms

Conditions

Recurrence; Breast Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: January 14, 2017
• Primary Completion: October 4, 2018
• Study Completion: October 4, 2018
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (24)