A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer (IXAMPLE2)
Tracking Information
Start Date ICMJE | August 2009 |
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Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 16, 2009) | Evidence of improved progression-free survival (PFS) with ixabepilone versus control chemotherapy (paclitaxel or doxorubicin) as confirmed by an Independent Radiologic Review Committee (IRRC) [ Time Frame: 34 months ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00883116 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 16, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | A Study of Ixabepilone as Second Line Therapy for Locally Advanced, Recurrent or Metastatic Endometrial Cancer |
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Official Title ICMJE | A Phase III, Open Label, Randomized, 2 Arm Study of Ixabepilone Administered Every 21 Days Versus Paclitaxel or Doxorubicin Administered Every 21 Days in Women With Advanced Endometrial Cancer Who Have Previously Been Treated With Chemotherapy |
Brief Summary | The primary purpose of this study is to investigate whether administration of ixabepilone results in superior outcome as measured by progression free survival (PFS) compared to standard chemotherapy (Paclitaxel or Doxorubicin) in women with advanced endometrial cancer that progressed after first line chemotherapy. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Endometrial Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 370 | ||||||||
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Estimated Completion Date | March 2014 | ||||||||
Estimated Primary Completion Date | July 2012 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Finland, France, Greece, Hungary, Italy, Mexico, Norway, Peru, Poland, Russian Federation, Spain, Sweden, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00883116 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CA163-196, 2008-007167-16 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/