WHO ICTRP trial

A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Nanosomal…

CTRI/2014/11/005204 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2014/11/005204
Public title A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Nanosomal Docetaxel Lipid Suspension for Injection in Locally Advanced or Metastatic Breast Cancer Patients.
Scientific title An Open Label, Parallel, Randomized Study to Evaluate the pharmacokinetics, Safety and Efficacy at three doses of Nanosomal Docetaxel Lipid Suspension for Injection in Locally Advanced or Metastatic Breast Cancer Patients after failure of prior chemotherapy. - NA
Primary sponsor Intas Pharmaceuticals Limited
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type PMS
Phase Post Marketing Surveillance
Countries India
Conditions Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Interventions Intervention1: NDLS_Intas: Dose: 60, 75 and 100 mg/m2, Mode of Administration: IV, Duration of treatment and frequency:6 cycles (21 days per cycle) Control Intervention1: Not Applicable: Not Applicable
Registration date Nov 14, 2014
Target size 90
Secondary IDs 740-14; Version 01; 17 Sep 14
Registry page ctri.nic.in

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