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

This study has been terminated.
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited Identifier:
First received: May 9, 2014
Last updated: October 20, 2016
Last verified: October 2016
Pharmacokinetic, bioequivalence study

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: 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 ] [ 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

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


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 identifier: NCT02136927

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 Identifier: NCT02136927     History of Changes
Other Study ID Numbers: CLR_12_10 
Study First Received: May 9, 2014
Last Updated: October 20, 2016
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on October 28, 2016