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Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects With Locally Recurrent or Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Sun Pharma Advanced Research Company Limited
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT02136927
First received: May 9, 2014
Last updated: November 18, 2014
Last verified: November 2014
  Purpose

This clinical study is designed to characterize pharmacokinetics and bioequivalence of PICN and Abraxane®, with safety evaluation


Condition Intervention Phase
Breast Cancer
Drug: PICN
Drug: Abraxane
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label, Two Period, Single Dose, Two Way Crossover, Bioavailability Study of Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects With Locally Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sun Pharma Advanced Research Company Limited:

Primary Outcome Measures:
  • Maximum observed concentration (Cmax) [ Time Frame: Pre-dose, post-dose up to 3 days ] [ Designated as safety issue: No ]
    Samples will be collected from all subjects at scheduled time-points: pre-dose and up to 3 days post-dose.


Other Outcome Measures:
  • Adverse events [ Time Frame: Day 3 ] [ Designated as safety issue: Yes ]
    AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0


Estimated Enrollment: 72
Study Start Date: August 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PICN
After reconstitution, PICN will be administered intravenously
Drug: PICN
Active Comparator: Abraxane Drug: Abraxane
260 mg/m2 every 3-weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02136927

Locations
India
BIBI General Hospital and Cancer Centre Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500024
Contact: Venkat Satya Suresh Attili, MBBS,MD,DM    040-24528122    sureshattili@yahoo.com   
Principal Investigator: Venkat Satya Suresh Attili, MBBS,MD,DM         
MNJ Institute of Oncology and Regional Cancer Center Not yet recruiting
Hyderabad, Andhra Pradesh, India, 500004
Contact: Malladi Krishna, MBBS,DNB,MD    40-23318414,23318424    rkmalladi@yahoo.com   
Principal Investigator: Malladi Krishna, MBBS,DNB,MD         
Sir Ganga Ram Hospital Not yet recruiting
New Delhi, Delhi, India, 110060
Contact: Shyam Aggarwal, MBBS,MD (Medicine)    011-25861002    drshyam_aggarwal@yahoo.com   
Principal Investigator: Shyam Aggarwal, MBBS,MD (Medicine)         
Kailash Cancer Hospital and Research Center Recruiting
Goraj, Gujarat, India, 391760
Contact: Niraj Bhatt, MBBS,MD (General Medicine),DM    91-2668-268040-50    nirajbhatt1974@gmail.com   
Principal Investigator: Niraj Bhatt, MBBS,MD (General Medicine),DM         
Amrita Institute of Medical Sciences (AIMS) Not yet recruiting
Cochin, Kerala, India, 682041
Contact: Pavithran Keechilat, MBBS,MD,DM    0484-4003003    pavithrank@aims.amrita.edu   
Principal Investigator: Pavithran Keechilat, MBBS,MD,DM         
Tata Memorial Hospital Not yet recruiting
Mumbai, Maharashtra, India, 400012
Contact: Jyoti , Bajpai    022-24177287    dr_jyotibajpai@yahoo.co.in   
Principal Investigator: Jyoti Bajpai, MBBS,MD,DM (Medical Oncology)         
Central India Cancer Research Institute Recruiting
Nagpur, Maharashtra, India, 440010
Contact: ajay Mehta, MBBS.MS    ajayonco@hotmail.com      
Principal Investigator: Ajay Mehta, MBBS.MS         
Shatabdi Super Specialty Hospital, Not yet recruiting
Nashik, Maharashtra, India, 422005
Contact: Shailesh Bondarde, MBBS,MD (Medicine)    0253-2501888    shaileshbondarde@yahoo.com   
Principal Investigator: Shailesh Bondarde, MBBS,MD (General Medicine),DM         
Deenanath Mangeshkar Hospital & Research Centre Not yet recruiting
Pune, Maharashtra, India, 411004
Contact: Chetan Dilip Deshmukh, MD    66023000    drchetandeshmukh@gmail.com   
Principal Investigator: Chetan Deelip Deshmukh, MBBS,MD,DM (Medical Oncology)         
KEM Hospital Research Centre Recruiting
Pune, Maharashtra, India, 411011
Contact: Minish Jain, MBBS,MD (General Medicine)    020 66037336    drminishjain@yahoo.in   
Principal Investigator: Minish Jain, MBBS,MD (General Medicine)         
Dr.Kamakshi Memorial Hospital Recruiting
Chennai, Tamil Nadu, India, 600100
Contact: Venkatesan Srinivasan, MBBS,MCCP,MDRT,FIPM    044-22469200,66300300    vsrinivasan09@gmail.com   
Principal Investigator: Venkatesan Srinivasan, MBBS,MCCP,MDRT,FIPM         
Meenakshi Mission Hospital and Research Centre Not yet recruiting
Madurai, Tamil Nadu, India, 625107
Contact: Kirushna Kumar Subramanian, MBBS,MD    0452-2588741-750    drkskk@yahoo.com   
Principal Investigator: Kirushna Kumar Subramanian, MBBS,MD         
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

No publications provided

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02136927     History of Changes
Other Study ID Numbers: CLR_12_10
Study First Received: May 9, 2014
Last Updated: November 18, 2014
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014