An open label, multicentric, dose ranging, single dose study to evaluate safety, tolerability & pharmacokinetics of Cabazitaxel lipid suspension for injection (Manufactured by Intas Pharmaceuticals Ltd.) in comparison with JEVTANA® (Cabazitaxel) injection (Manufactured by Sanofi-aventis) in patients with advanced solid malignancies refractory to conventional treatment.

Trial Profile

An open label, multicentric, dose ranging, single dose study to evaluate safety, tolerability & pharmacokinetics of Cabazitaxel lipid suspension for injection (Manufactured by Intas Pharmaceuticals Ltd.) in comparison with JEVTANA® (Cabazitaxel) injection (Manufactured by Sanofi-aventis) in patients with advanced solid malignancies refractory to conventional treatment.

Recruiting
Phase of Trial: Phase I

Latest Information Update: 15 Jul 2016

At a glance

  • Drugs Cabazitaxel (Primary)
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Intas Pharmaceuticals
  • Most Recent Events

    • 15 Jul 2016 New source identified and integrated (Clinical Trials Registry - India CTRI/2015/06/005948)
    • 15 Jul 2016 New trial record
    • 07 Jun 2016 Interim results (n=11) presented at the 52nd Annual Meeting of the American Society of Clinical Oncology
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