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A Study of Oraxol® in Gastric Cancer Patients

NCT01491217 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2011-12-13

No results posted yet for this study

Summary

The main objectives of this study are to determine the maximum tolerated dose (MTD) and recommend dose (RD) of Oraxol® in Phase I and to determine the objective response rate of Oraxol® in Phase II.

Conditions

  • Advanced Metastatic Gastric Cancer
  • Recurrent Gastric Cancer

Interventions

DRUG

Paclitaxel

HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Principal Investigators

  • Yung-Jue Bang, MD. Ph.D · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-03-31
Completion
2012-12-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT01491217 on ClinicalTrials.gov