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Determine MTD, Evaluate Efficacy and Safety of Genexol®-PM Plus Carboplatin With Advanced Ovarian Cancer

NCT00877253 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2012-06-12

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose of Genexol®-PM plus Carboplatin and evaluate the efficacy and safety of Genexol®-PM plus Carboplatin regimen in subjects with advanced ovarian cancer.

Conditions

Interventions

DRUG

Genexol-PM 220mg/㎡, Carboplatin 5AUC

Genexol-PM 220mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.

DRUG

Genexol-PM 260mg/㎡, Carboplatin 5AUC

Genexol-PM 260mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.

DRUG

Genexol-PM 300mg/㎡, Carboplatin 5AUC

Genexol-PM 300mg/m2 by IV infusion over 3 hours on day 1 of every 21 day cycle. Carboplatin, AUC 5 given by IV infusion over 30-60 minutes on day 1 of every 21 day cycle.

Sponsors & Collaborators

  • Samyang Biopharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Soon Beom Kang, MD, PhD · Seoul National University Hospital

  • Yong Man Kim, MD, PhD · Asan Medical Center

  • Byoung Gie Kim, MD, PhD · Samsung Medical Center

  • Young Tae Kim, MD, PhD · Yonsei University Health System Severance Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00877253 on ClinicalTrials.gov