Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier:
NCT02136927
First received: May 9, 2014
Last updated: October 20, 2016
Last verified: October 2016

May 9, 2014
October 20, 2016
August 2014
April 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT02136927 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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
Same as current
 
Bioavailability Study of SPARC1210 and Reference1210 in Subjects With Metastatic Breast Cancer
Not Provided
Pharmacokinetic, bioequivalence study
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: SPARC1210
  • Drug: Reference1210
  • Experimental: SPARC1210
    Intravenous administration of SPARC1210
    Intervention: Drug: SPARC1210
  • Active Comparator: Reference1210
    Intravenous administration of Reference1210
    Intervention: Drug: Reference1210
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
33
April 2016
April 2016   (final data collection date for primary outcome measure)

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
Female
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
India
 
NCT02136927
CLR_12_10
No
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
October 2016

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