WHO ICTRP trial

Phase 1 safety, tolerability, and pharmacokinetic study of Docetaxel…

CTRI/2010/091/001122 · Clinical Trials Registry India (CTRI) · Not Recruiting

Key facts

Trial ID CTRI/2010/091/001122
Public title Phase 1 safety, tolerability, and pharmacokinetic study of Docetaxel nano-dispersion: A randomized, open label, dose ranging, active controlled, comparative, parallel groups, and multi-centric study.
Scientific title Phase 1 safety, tolerability, and pharmacokinetic study of Docetaxel nano-dispersion: A randomized, open label, dose ranging, active controlled, comparative, parallel groups, and multi-centric study.
Primary sponsor Sun Pharma Advanced Research Company Ltd
Registry Clinical Trials Registry India (CTRI)
Recruitment status Not Recruiting
Study type Interventional
Phase Phase 1
Countries India
Conditions Health Condition 1: null- locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment
Interventions Intervention1: Docetaxel injection concentrate for nano-dispersion (DICN): 1 Cycle Control Intervention1: Polysorbate 80 based Docetaxel formulation: 1 cycle
Registration date Aug 9, 2010
Target size 30
Secondary IDs CLR_09_01
Registry page ctri.nic.in

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