Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
NCT ID: NCT01599754
Last Updated: 2019-09-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
724 participants
INTERVENTIONAL
2012-04-30
2018-05-31
Brief Summary
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Detailed Description
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Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Axitinib
Axitinib
Axitinib 5 mg twice daily
Placebo
Placebo
Placebo twice daily
Interventions
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Axitinib
Axitinib 5 mg twice daily
Placebo
Placebo twice daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female, age \>=18 years (age \>=20 years in Japan, Korea and Taiwan).
3. Patients must be diagnosed with one of the following based on American Joint Committee on Cancer (AJCC) TNM staging version 2010, Eastern Collaborative Oncology Group (ECOG) performance status (PS):
* pT2, pN0 or pNx, M0 and ECOG PS 0-1
* pT3, pN0 or pNx, M0 and ECOG PS 0-1
* pT4, pN0 or pNx, M0 and ECOG PS 0-1
* Any pT, pN1, M0 and ECOG PS 0-1
4. Patients must have histologically confirmed preponderant, defined as \>50%, clear cell RCC.
5. Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
6. Patients must not have received any previous anti angiogenic treatment.
7. Patients must have adequate organ function.
Exclusion Criteria
2. National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage \<4 weeks of date of randomization.
3. Diagnosis of any non-RCC malignancy within the 5 years from date of randomization, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months.
4. Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
5. Gastrointestinal abnormalities
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
SFJ Pharmaceuticals, Inc.
INDUSTRY
SFJ Pharma Ltd. II
INDUSTRY
Responsible Party
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Locations
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La Jolla, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Pleasant Hill, California, United States
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Ocala, Florida, United States
Atlanta, Georgia, United States
Annapolis, Maryland, United States
Baltimore, Maryland, United States
Saint Paul, Minnesota, United States
Omaha, Nebraska, United States
Hackensack, New Jersey, United States
Albany, New York, United States
New York, New York, United States
Portland, Oregon, United States
Charleston, South Carolina, United States
Chattanooga, Tennessee, United States
Austin, Texas, United States
Bedford, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Norfolk, Virginia, United States
Seattle, Washington, United States
Beijing, , China
Changchun, , China
Chongqing, , China
Dalian, , China
Guangzhou, , China
Hangzhou, , China
Jinan, , China
Nanchang, , China
Shanghai, , China
Suzhou, , China
Tianjin, , China
Wuhan, , China
Besançon, , France
Bordeaux, , France
Hyères, , France
Le Mans, , France
Lyon, , France
Marseille, , France
Paris, , France
Rennes, , France
Saint-Herblain, , France
Suresnes, , France
Vandœuvre-lès-Nancy, , France
Hong Kong, , Hong Kong
Ahmeadbad, , India
Aurangabad, , India
Bangalore, , India
Chennai, , India
Hyderabad, , India
Karamsad, , India
Kochi, , India
Kolkota, , India
Lucknow, , India
Ludhiana, , India
Mangalore, , India
Manipal, , India
Mumbai, , India
Nashik, , India
New Delhi, , India
Pune, , India
Surat, , India
Visakhapatnam, , India
Aichi, , Japan
Akita, , Japan
Aomori, , Japan
Chiba, , Japan
Fukuoka, , Japan
Gifu, , Japan
Hokkaido, , Japan
Hyōgo, , Japan
Kagawa, , Japan
Kanagawa, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Nagasaki, , Japan
Nigata-honmachi, , Japan
Osaka, , Japan
Shizuoka, , Japan
Tokushima, , Japan
Tokyo, , Japan
Yamagata, , Japan
Yamaguchi, , Japan
Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gyeonggi-do, , South Korea
Jeonnam, , South Korea
Seoul, , South Korea
Barcelona, , Spain
Donostia / San Sebastian, , Spain
Leganés, , Spain
Llobregat, , Spain
Madrid, , Spain
Oviedo, , Spain
Seville, , Spain
Valencia, , Spain
Zaragoza, , Spain
Taichung, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Countries
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References
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Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Other Identifiers
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AP311736
Identifier Type: -
Identifier Source: org_study_id
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