Open-label, Multicenter, Phase I Trial to Evaluate Efficacy and Safety of the Combination Therapy of Genexol®-PM Plus Carboplatin as a Firstline Treatment in Subjects With Advanced Ovarian Cancer
This is a phase I trial to determine the maximum tolerated dose and recommended phase II
dose of the combination therapy with Genexol®-PM and Carboplatin and to evaluate the
efficacy and safety of Genexol®-PM when administered with Carboplatin in subjects with
advanced ovarian cancer after debulking surgery.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the MTD and recommended phase II dose of the combination therapy with Genexol-PM and Carboplatin in subjects with advanced ovarian cancer.
until either MTD is achieved or maximum planned dose is tested
Yes
Soon Beom Kang, MD, PhD
Principal Investigator
Seoul National University Hospital
Korea: Food and Drug Administration
GPMOC201
NCT00877253
May 2008
June 2009
Name | Location |
---|