Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

April 27, 2017 updated by: Samyang Biopharmaceuticals Corporation

A Open-label, Randomized, Parallel, Phase III Trial to Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol®(Conventional Paclitaxel With Cremorphor EL) in Subjects With Recurrent or Metastatic Breast Cancer

Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Subjects should meet all of the following criteria to participate in the trial.

  1. Subjects who aged 18 years or older.
  2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
  3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
  4. If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
  5. Subjects who have measurable disease in accordance with the RECIST criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Genexol®-PM
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
Drug: Genexol-PM®
Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
Active Comparator: Genexol®
This is a open-labeled, randomized, parallel, phase III Trial. Up to 106 elgible patients will be enrolled in each treatment arm(Total 212 subjects will recruited) according to the trial design. Patients will be randomly allocated to arm A (Genexol-PM) or arm B (Paclitaxel).
Drug: Genexol®
Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 6 months
Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response
Time Frame: Event driven
To evaluate the efficacy of Genexol®-PM relative to Genexol® as measured by Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response.
Event driven
Safety and toxicity
Time Frame: Throughout study
To compare the safety and toxicity of Genexol®-PM with those of Genexol®
Throughout study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samyang Biopharmaceuticals Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2008

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

April 3, 2009

First Submitted That Met QC Criteria

April 3, 2009

First Posted (Estimate)

April 6, 2009

Study Record Updates

Last Update Posted (Actual)

May 1, 2017

Last Update Submitted That Met QC Criteria

April 27, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GPMBC301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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