An Open-label, Randomized, Multi-center, Single-Dose, 2-Sequence, 2-Period, Crossover, Comparative Bioequivalence Study of IG-001 (Cb-paclitaxel) 260 mg/m2 Versus Nab-paclitaxel 260 mg/m2 Administered Intravenously With an Open-Label Extension of IG-001 in Patients With Metastatic or Locally Recurrent Breast Cancer

Trial Profile

An Open-label, Randomized, Multi-center, Single-Dose, 2-Sequence, 2-Period, Crossover, Comparative Bioequivalence Study of IG-001 (Cb-paclitaxel) 260 mg/m2 Versus Nab-paclitaxel 260 mg/m2 Administered Intravenously With an Open-Label Extension of IG-001 in Patients With Metastatic or Locally Recurrent Breast Cancer

Completed
Phase of Trial: Phase I

Latest Information Update: 29 Mar 2016

At a glance

  • Drugs Paclitaxel (Primary)
  • Indications Advanced breast cancer
  • Focus Pharmacokinetics; Registrational
  • Acronyms TRIBECA
  • Sponsors IgDraSol; Sorrento Therapeutics
  • Most Recent Events

    • 19 May 2015 Status changed from active, no longer recruiting to completed, as reported by Sorrento Therapeutics media release.
    • 04 May 2015 Results published in Sorrento Therapeutics media release.
    • 10 Feb 2015 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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