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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02136927
First Posted: May 13, 2014
Last Update Posted: October 21, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
  Purpose
Pharmacokinetic, bioequivalence study

Condition Intervention Phase
Breast Cancer Drug: SPARC1210 Drug: Reference1210 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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 ]
    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 ]
    AEs encountered following dosing with PICN or Abraxane® will be recorded as per CTCAE, Version 4.0


Enrollment: 33
Study Start Date: August 2014
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPARC1210
Intravenous administration of SPARC1210
Drug: SPARC1210
Active Comparator: Reference1210
Intravenous administration of Reference1210
Drug: Reference1210

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02136927


Locations
India
SPARC Site 12
Hyderabad, Andhra Pradesh, India
SPARC Site 9
Hyderabad, Andhra Pradesh, India
SPARC Site 6
New Delhi, Delhi, India
SPARC Site 2
Goraj, Gujarat, India
SPARC Site 8
Cochin, Kerala, India
SPARC Site 11
Mumbai, Maharashtra, India
SPARC Site 5
Nagpur, Maharashtra, India
SPARC Site 4
Nashik, Maharashtra, India
SPARC Site 1
Pune, Maharashtra, India
SPARC Site 3
Pune, Maharashtra, India
SPARC Site 10
Chennai, Tamil Nadu, India
SPARC Site 7
Madurai, Tamil Nadu, India
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
  More Information

Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT02136927     History of Changes
Other Study ID Numbers: CLR_12_10
First Submitted: May 9, 2014
First Posted: May 13, 2014
Last Update Posted: October 21, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases