Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00920816
First received: June 11, 2009
Last updated: May 6, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Neoplasms |
Drug: Axitinib (AG-013736) Drug: Sorafenib |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Axitinib (AG-013736) For the Treatment of Metastatic Renal Cell Cancer |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Progression-Free Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Response Rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Safety and Tolerability on Axitinib [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Duration of Response in Each Arm [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Kidney Specific Symptoms and Health Status [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Enrollment: | 204 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2014 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: A |
Drug: Axitinib (AG-013736)
axitinib will be given at a starting dose of 5 mg BID with continuous dosing
|
| Active Comparator: B |
Drug: Sorafenib
sorafenib will be given at a dose of 400 mg BID continuous dosing
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00920816
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| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33176 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33143 | |
| United States, Illinois | |
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| Arlington Heights, Illinois, United States, 60005 | |
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| Niles, Illinois, United States, 60714 | |
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| Winfield, Illinois, United States, 60190 | |
| United States, Indiana | |
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| Carmel, Indiana, United States, 46032 | |
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| Fishers, Indiana, United States, 46037 | |
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| Greenfield, Indiana, United States, 46140 | |
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| Indianapolis, Indiana, United States, 46227 | |
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| Indianapolis, Indiana, United States, 46219 | |
| United States, Missouri | |
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| Columbia, Missouri, United States, 65201 | |
| United States, Nebraska | |
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| Omaha, Nebraska, United States, 68114 | |
| United States, Nevada | |
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| Henderson, Nevada, United States, 89052 | |
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| Henderson, Nevada, United States, 89074 | |
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| Las Vegas, Nevada, United States, 89148 | |
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| Las Vegas, Nevada, United States, 89128 | |
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| Las Vegas, Nevada, United States, 89169 | |
| United States, New Jersey | |
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| Morristown, New Jersey, United States, 07962 | |
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| Parsippany, New Jersey, United States, 07054 | |
| United States, New York | |
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| Albany, New York, United States, 12208 | |
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| Albany, New York, United States, 12206 | |
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| Latham, New York, United States, 12110 | |
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| Rexford, New York, United States, 12148 | |
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| Troy, New York, United States, 12180 | |
| United States, North Carolina | |
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| Cary, North Carolina, United States, 27518 | |
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| Raleigh, North Carolina, United States, 27607 | |
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| Raleigh, North Carolina, United States, 27614 | |
| United States, Oregon | |
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| Portland, Oregon, United States, 97225 | |
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| Portland, Oregon, United States, 97227 | |
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| Portland, Oregon, United States, 97213 | |
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| Tualatin, Oregon, United States, 97062 | |
| United States, Pennsylvania | |
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| Hershey, Pennsylvania, United States, 17033-0850 | |
| United States, South Carolina | |
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| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
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| Amarillo, Texas, United States, 79106 | |
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| Beaumont, Texas, United States, 77702-1449 | |
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| Dallas, Texas, United States, 75246 | |
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| Fort Worth, Texas, United States, 76177 | |
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| Fort Worth, Texas, United States, 76132 | |
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| Fort Worth, Texas, United States, 76104 | |
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| Kerrville, Texas, United States, 78028 | |
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| McAllen, Texas, United States, 78503 | |
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| Midland, Texas, United States, 79701 | |
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| San Antonio, Texas, United States, 78217 | |
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| San Antonio, Texas, United States, 78258-3912 | |
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| Webster, Texas, United States, 77598-4420 | |
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| Weslaco, Texas, United States, 78596 | |
| United States, Virginia | |
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| Christiansburg, Virginia, United States, 24073 | |
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| Low Moor, Virginia, United States, 24457 | |
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| Roanoke, Virginia, United States, 24014 | |
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| Salem, Virginia, United States, 24153 | |
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| Wytheville, Virginia, United States, 24382 | |
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| Vancouver, Washington, United States, 98686 | |
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| Vancouver, Washington, United States, 98684 | |
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| Wenatchee, Washington, United States, 98801 | |
| Bosnia and Herzegovina | |
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| Banja Luka, Bosnia and Herzegovina, 78000 | |
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| Sarajevo, Bosnia and Herzegovina, 71000 | |
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| Tuzla, Bosnia and Herzegovina, 75000 | |
| Bulgaria | |
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| Sofia, Bulgaria, 1756 | |
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| Varna, Bulgaria, 9000 | |
| Chile | |
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| Temuco, Cautin, Chile, 4810469 | |
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| Providencia, Santiago, RM, Chile, 7501088 | |
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| Santiago, RM, Chile, 7500710 | |
| China, Fujian | |
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| FuZhou, Fujian, China, 350025 | |
| China, Guangdong | |
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| Guangzhou, Guangdong, China, 510060 | |
| China, Jiangsu | |
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| Nanjing, Jiangsu, China, 210002 | |
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| Nanjing, Jiangsu, China, 210029 | |
| China, Jilin | |
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| Changchun, Jilin, China, 130012 | |
| China, Shanghai | |
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| Shanghai, Shanghai, China, 200127 | |
| China, Sichuan | |
| Pfizer Investigational Site | |
| Chengdu, Sichuan, China, 610041 | |
| China, Zhejiang | |
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| Hangzhou, Zhejiang, China, 310016 | |
| China | |
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| Beijing, China, 100036 | |
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| Beijing, China, 100021 | |
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| Beijing, China, 100034 | |
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| Beijing, China, 100853 | |
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| Chongqing, China, 400038 | |
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| Guangzhou, China, 510515 | |
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| Nanjing, China, 210009 | |
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| Shanghai, China, 200032 | |
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| Shen Yang, China, 110001 | |
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| Tianjin, China, 300060 | |
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| Tianjin, China, 300211 | |
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| Xi'an, China, 710032 | |
| India | |
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| Hyderabad, Andhra Pradesh, India, 500024 | |
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| Bangalore, Karnataka, India, 560038 | |
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| Bangalore, Karnataka, India, 560070 | |
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| Bangalore, Karnataka, India, 560068 | |
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| Nagpur, Maharashtra, India, 440012 | |
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| Nashik, Maharashtra, India, 422 005 | |
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| Nasik, Maharashtra, India, 422004 | |
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| Pune, Maharashtra, India, 411 004 | |
| Malaysia | |
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| Kuala Lumpur, Malaysia, 59100 | |
| Mexico | |
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| Mexico, DF, Mexico, 14000 | |
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| Mexico City, Distrito Federal, Mexico, 06726 | |
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| Toluca, Estado de Mexico, Mexico, 50080 | |
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| Aguascalientes, Mexico, 20000 | |
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| Oaxaca, Mexico, 68000 | |
| Philippines | |
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| Quezon City, Diliman, Philippines | |
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| Makati City, Philippines, 1200 | |
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| Manila, Philippines, 1000 | |
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| Quezon City, Philippines | |
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| Quezon City, Philippines, 1102 | |
| Romania | |
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| Timisoara, Jud. Timis, Romania, 300239 | |
| Pfizer Investigational Site | |
| Cluj-Napoca, Romania, 400015 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 125284 | |
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| Moscow, Russian Federation, 111033 | |
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| Moscow, Russian Federation, 105005 | |
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| Ryazan, Russian Federation, 390026 | |
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| Ryazan, Russian Federation, 390011 | |
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| Saint-Petersburg, Russian Federation, 197022 | |
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| Ufa, Russian Federation, 450054 | |
| South Africa | |
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| Port Elizabeth, South Africa, 6045 | |
| Taiwan | |
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| Taichung, Taiwan, 407 | |
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| Taipei, Taiwan, 112 | |
| Ukraine | |
| Pfizer Investigational Site | |
| Dnipropetrovsk, Ukraine, 49005 | |
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| Kharkiv, Ukraine, 61037 | |
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| Kyiv, Ukraine, 04053 | |
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| Kyiv, Ukraine, 03115 | |
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| Lviv, Ukraine, 79031 | |
| Pfizer Investigational Site | |
| Zaporizhzhya, Ukraine, 69040 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00920816 History of Changes |
| Other Study ID Numbers: | A4061051 |
| Study First Received: | June 11, 2009 |
| Last Updated: | May 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Axitinib in First & Second Line Treatment of Patients With Metastatic Renal Cell Cancer |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma, Renal Cell Kidney Neoplasms Adenocarcinoma Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site |
Kidney Diseases Urologic Diseases Sorafenib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 16, 2013