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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Samyang Biopharmaceuticals Corporation.
Recruitment status was  Recruiting
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

April 3, 2009
June 10, 2012
December 2008
December 2012   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00876486 on ClinicalTrials.gov Archive Site
  • 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®
Not Provided
Not Provided
Not Provided
 
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Genexol-PM®
    Genexol-PM® 260mg/m2, intravenous infusion over 3 hours, every 3 weeks
  • Drug: Genexol®
    Genexol® 175mg/m2, intravenous infusion over 3 hours, every 3 weeks
  • 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).
    Intervention: Drug: Genexol-PM®
  • 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).
    Intervention: Drug: Genexol®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
212
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Korea, Republic of
 
NCT00876486
GPMBC301
No
Samyang Biopharmaceuticals Corporation
Samyang Biopharmaceuticals Corporation
Not Provided
Not Provided
Samyang Biopharmaceuticals Corporation
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP