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

This study is currently recruiting participants.
Verified June 2012 by Samyang Biopharmaceuticals Corporation
Sponsor:
Information provided by (Responsible Party):
Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT00876486
First received: April 3, 2009
Last updated: June 10, 2012
Last verified: June 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Genexol-PM®
Drug: Genexol®
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Samyang Biopharmaceuticals Corporation:

Primary Outcome Measures:
  • Objective Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Evaluate the efficacy of Genexol®-PM versus Genexol® in subjects with recurrent or metastatic breast cancer based on Objective Response Rate.


Secondary Outcome Measures:
  • Overall Survival, Progress Free Survival, Time to Tumor Progression, Duration of Overall Response [ Time Frame: Event driven ] [ Designated as safety issue: No ]
    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.

  • Safety and toxicity [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
    To compare the safety and toxicity of Genexol®-PM with those of Genexol®


Estimated Enrollment: 212
Study Start Date: December 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00876486

Locations
Korea, Republic of
National Cancer Center Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of
Contact: Sunwoo Park     82-31-920-1228 ext 1228     sophie486@lycos.co.kr    
Principal Investigator: Jungsil Ro, MD,PhD            
Sponsors and Collaborators
Samyang Biopharmaceuticals Corporation
  More Information

No publications provided

Responsible Party: Samyang Biopharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT00876486     History of Changes
Other Study ID Numbers: GPMBC301
Study First Received: April 3, 2009
Last Updated: June 10, 2012
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Nonoxynol
Octoxynol
Spermatocidal Agents
 Antispermatogenic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses
Contraceptive Agents, Male

ClinicalTrials.gov processed this record on May 19, 2013