Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer

May 2, 2019 updated by: Sun Pharma Advanced Research Company Limited
Pharmacokinetic, bioequivalence study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • SPARC Site 12
      • Hyderabad, Andhra Pradesh, India
        • SPARC Site 9
    • Delhi
      • New Delhi, Delhi, India
        • SPARC Site 6
    • Gujarat
      • Goraj, Gujarat, India
        • SPARC Site 2
    • Kerala
      • Cochin, Kerala, India
        • SPARC Site 8
    • Maharashtra
      • Mumbai, Maharashtra, India
        • SPARC Site 11
      • Nagpur, Maharashtra, India
        • SPARC Site 5
      • Nashik, Maharashtra, India
        • SPARC Site 4
      • Pune, Maharashtra, India
        • SPARC Site 1
      • Pune, Maharashtra, India
        • SPARC Site 3
    • Tamil Nadu
      • Chennai, Tamil Nadu, India
        • SPARC Site 10
      • Madurai, Tamil Nadu, India
        • SPARC Site 7

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The subject has given written, informed consent and is available for the entire study.
  • Histologically or cytologically confirmed diagnosis of breast cancer;
  • Locally recurrent or metastatic breast cancer for which taxane-based therapy is a rational treatment option;
  • Age 18 years or more

Exclusion Criteria:

  • Known hypersensitivity to both the study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol);
  • Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy;
  • Pre-existing clinically significant peripheral neuropathy (Grade 2 or higher according to CTCAE, Version 4.0);
  • Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPARC1210
Intravenous administration of SPARC1210
Drug: SPARC1210
Active Comparator: Reference1210
Intravenous administration of Reference1210
Drug: Reference1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Pre-dose, post-dose up to 3 days
Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.
Pre-dose, post-dose up to 3 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events
Time Frame: Day 3
AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0
Day 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

May 9, 2014

First Submitted That Met QC Criteria

May 9, 2014

First Posted (Estimate)

May 13, 2014

Study Record Updates

Last Update Posted (Actual)

May 3, 2019

Last Update Submitted That Met QC Criteria

May 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_12_10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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