Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
NCT00920816
ABOUT THIS STUDY
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- Histologically documented metastatic renal cell cancer with a component of clear cell histology.
- Evidence of measurable disease.
- Patients with mRCC must have received no prior systemic first-line therapy or must have progressive disease per RECIST (version 1.0) after one prior systemic first line regimen for metastatic disease containing sunitinib, cytokine(s), or both.
- Prior treatment for metastatic renal cell cancer with more that one systemic first
line therapy.
- Major surgery less that 4 weeks or radiation less than 2 weeks of starting study drug.
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Descriptive Information | |||||||
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Brief Title ICMJE | Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer | ||||||
Official Title ICMJE | AG-013736 (AXITINIB) FOR THE TREATMENT OF METASTATIC RENAL CELL CANCER | ||||||
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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Kidney Neoplasms | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE | 492 | ||||||
Original Estimated Enrollment ICMJE | 200 | ||||||
Estimated Study Completion Date ICMJE | January 6, 2021 | ||||||
Actual Primary Completion Date | July 27, 2012 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Bosnia and Herzegovina, Bulgaria, Chile, China, India, Malaysia, Mexico, Philippines, Romania, Russian Federation, South Africa, Taiwan, Ukraine, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00920816 | ||||||
Other Study ID Numbers ICMJE | A4061051 2010-018585-23 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | October 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |