Safety of Genexol PM and Carboplatin as First-line Therapy in Ovarian Cancer
NCT05300828 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 600
Last updated 2023-06-26
Summary
To evaluate the safety profile of Genexol PM combination with carboplatin for patients with newly diagnosed ovarian cancer. We hypothesized Genexol PM can be safely administered to newly diagnosed ovarian cancer patients compared to conventional paclitaxel/carboplatin combination therapy. Therefore, we will compare the prospective cohort with a historical comparison with patients administered paclitaxel/carboplatin and paclitaxel/carboplatin/bevacizumab combination therapy.
Conditions
Interventions
- DRUG
-
Genexl PM
Every three weeks, after intravenous infusion of 260 mg/m2 for 3 hours, followed by carboplatin AUC 5 for 3 hours.
Sponsors & Collaborators
-
Samyang Biopharmaceuticals Corporation
collaborator INDUSTRY -
Seoul National University Hospital
lead OTHER
Principal Investigators
-
Hee Seung Kim · Seoul National University Hospital
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-10-19
- Primary Completion
- 2022-04-30
- Completion
- 2022-12-31
Countries
- South Korea
Study Locations
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