A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer
Tracking Information
Start Date ICMJE | December 2008 |
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Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: August 12, 2008) | To compare the progression-free survival (PFS) in the ixabepilone plus carboplatin arm to that in the paclitaxel plus carboplatin arm for the subgroup with βIII tubulin positive tumors (βIII tubulin positive subgroup). [ Time Frame: Assessed by tumor measurements (scans) every 6 weeks ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: July 25, 2008) | To compare the progression-free survival (PFS) in the ixabepilone plus carboplatin arm to that in the paclitaxel plus carboplatin arm for the subgroup with βIII tubulin positive tumors (βIII tubulin positive subgroup). [ Time Frame: Assessed by tumor measurements (scans) every 6 weeks ] |
Change History | Complete list of historical versions of study NCT00723957 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: August 12, 2008) |
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Original Secondary Outcome Measures ICMJE (submitted: July 25, 2008) |
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Descriptive Information
Brief Title ICMJE | A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer |
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Official Title ICMJE | A Randomized Phase 2 Study of Ixabepilone Plus Carboplatin and Paclitaxel Plus Carboplatin in Patients With Advanced Non-Small Cell Lung Cancer |
Brief Summary | The purpose of this study is to determine if Ixabepilone combined with carboplatin is better than paclitaxel combined with carboplatin in a subgroup of patients with non-small cell lung cancer (NSCLC) whose tumors are positive for the βΙII isoform of tubulin |
Detailed Description | |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Condition ICMJE | Advanced/Metastatic Non-Small Cell Lung Cancer |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Recruitment Status ICMJE | Recruiting | ||||||||
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Estimated Enrollment ICMJE | 260 | ||||||||
Estimated Completion Date | February 2011 | ||||||||
Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Argentina, Australia, France, Germany, Italy, Korea, Republic of, Russian Federation, Spain, Taiwan |
Administrative Information
NCT ID ICMJE | NCT00723957 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CA163-163 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/