Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer
Tracking Information
Start Date ICMJE | July 2008 |
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Estimated Primary Completion Date | July 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: May 12, 2008) | Progression-Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00678392 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: May 12, 2008) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer |
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Official Title ICMJE | Axitinib (AG 013736) As Second Line Therapy For Metastatic Renal Cell Cancer: Axis Trial |
Brief Summary | The study is designed to demonstrate that axitinib (AG-013736) is superior to sorafenib in delaying tumor progression in patients with metastatic renal cell cancer after failure of one first line regimen. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Kidney Neoplasms |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 650 | ||||||||
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Estimated Completion Date | July 2010 | ||||||||
Estimated Primary Completion Date | July 2010 (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, Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Ireland, Italy, Japan, Korea, Republic of, Netherlands, Poland, Russian Federation, Singapore, Slovakia, Spain, Sweden, Taiwan, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00678392 | ||||
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Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study ID Numbers ICMJE | A4061032, AXIS TRIAL | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer |
Source: http://clinicaltrials.gov/