Trial intelligence / Profile preview

Bioequivalence Study of DOXIL/CAELYX from New Manufacturing Site in Advanced Solid Tumors

NCT02081495Phase 1Completed

Sponsor
Janssen Pharmaceutical
Start
Aug 2014
Primary completion
Nov 2015
Modality
Targeted Liposomes, Stealth (PEGylated) Liposomes, Conventional Liposomes
Countries
4
01

Overview

Phase 1, randomised, open-label trial of pegylated liposomal doxorubicin in solid tumor, ovarian cancer and breast cancer (2 arms), sponsored by Janssen Pharmaceutical. Primary endpoints: Maximum observed plasma concentration of encapsulated doxorubicin, Time to reach maximum observed plasma concentration of encapsulated doxorubicin and 1 more. Started Aug 2014; status: completed.

02

Drugs

pegylated liposomal doxorubicin
03

Conditions

solid tumorovarian cancerbreast cancer

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