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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

May 9, 2014
November 18, 2014
August 2014
December 2014   (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 Paclitaxel Injection Concentrate for Nano-dispersion (PICN) and Abraxane® in Subjects With Locally Recurrent or Metastatic Breast Cancer
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

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

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: PICN
  • Drug: Abraxane
    260 mg/m2 every 3-weekly
  • Experimental: PICN
    After reconstitution, PICN will be administered intravenously
    Intervention: Drug: PICN
  • Active Comparator: Abraxane
    Intervention: Drug: Abraxane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
December 2014
December 2014   (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 and older
No
India
 
NCT02136927
CLR_12_10
No
Sun Pharma Advanced Research Company Limited
Sun Pharma Advanced Research Company Limited
Not Provided
Not Provided
Sun Pharma Advanced Research Company Limited
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP