Study Stopped
Primary endpoint did not reach statistical significance
Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
ATLAS
Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC
1 other identifier
interventional
724
9 countries
106
Brief Summary
The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2012
Longer than P75 for phase_3
106 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 11, 2012
CompletedFirst Posted
Study publicly available on registry
May 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
August 28, 2019
CompletedSeptember 20, 2019
September 1, 2019
5.5 years
May 11, 2012
May 31, 2019
September 18, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
DFS is defined as time interval from the date of randomization to first date of recurrence/relapse (distant or local recurrence of \[RCC\] or occurrence of a secondary malignancy {occurrence of a second primary cancer other than RCC} or death). For participants with no DFS event, DFS was censored at date of last scan prior to time of analyses. Participants alive who did not have post-baseline disease assessments, DFS was censored at randomization. Participants who received further anti-tumor therapy prior to recurrence or occurrence of a secondary malignancy or death, DFS was censored on date of last scan prior to taking anti-tumor medication. Participants who missed 2 or more consecutive tumor scans immediately followed by an event were censored at date of last objective tumor assessment prior to missing/not readable scan.
From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
Secondary Outcomes (8)
Overall Survival (OS)
From randomization date until death due to any cause (up to 5 years)
Number of Participants With Treatment-Emergent Adverse Events (AE) and Serious Adverse Events (SAEs)
From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Treatment-Emergent Treatment Related Adverse Events and Serious Adverse Events (SAEs)
From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) By Severity
From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities By Maximum CTCAE Grade: Hematology
From Day 1 up to 28 days after last dose (maximum duration of 3 years)
- +3 more secondary outcomes
Study Arms (2)
Axitinib
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patients must have no evidence of macroscopic residual disease or metastatic disease.
- Male or female, age \>=18 years (age \>=20 years in Japan, Korea and Taiwan).
- 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
- Patients must have histologically confirmed preponderant, defined as \>50%, clear cell RCC.
- Patients must not have received any previous systemic (includes chemotherapeutic, hormonal, or immunotherapeutic) treatment for RCC.
- Patients must not have received any previous anti angiogenic treatment.
- Patients must have adequate organ function.
You may not qualify if:
- Histologically undifferentiated carcinomas, sarcomas, collecting duct carcinoma, lymphoma, or patients with any metastatic renal sites.
- National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 hemorrhage \<4 weeks of date of randomization.
- 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.
- 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.
- Gastrointestinal abnormalities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SFJ Pharma Ltd. IIlead
- Pfizercollaborator
- SFJ Pharmaceuticals, Inc.collaborator
Study Sites (106)
Unknown Facility
La Jolla, California, 92093, United States
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Los Angeles, California, 90033, United States
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Palo Alto, California, 94304, United States
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Pleasant Hill, California, 94523, United States
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Denver, Colorado, 80218, United States
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Washington D.C., District of Columbia, 20007, United States
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Ocala, Florida, 34471, United States
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Atlanta, Georgia, 30322, United States
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Annapolis, Maryland, 21403, United States
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Baltimore, Maryland, 21231-1000, United States
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Saint Paul, Minnesota, 55118, United States
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Omaha, Nebraska, 68198, United States
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Hackensack, New Jersey, 07601, United States
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Albany, New York, 12208, United States
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New York, New York, 10467, United States
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Portland, Oregon, 97227, United States
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Charleston, South Carolina, 29412, United States
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Chattanooga, Tennessee, 37421, United States
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Austin, Texas, 78731, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75203, United States
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Houston, Texas, 77024, United States
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San Antonio, Texas, 78217, United States
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San Antonio, Texas, 78234, United States
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Norfolk, Virginia, 23502, United States
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Seattle, Washington, 95109, United States
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Beijing, China
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Changchun, China
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Chongqing, China
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Dalian, China
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Guangzhou, China
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Hangzhou, China
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Jinan, China
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Nanchang, China
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Shanghai, China
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Suzhou, China
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Tianjin, China
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Wuhan, China
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Besançon, France
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Bordeaux, France
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Hyères, France
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Le Mans, France
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Lyon, France
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Marseille, France
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Paris, France
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Rennes, France
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Saint-Herblain, France
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Suresnes, France
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Vandœuvre-lès-Nancy, France
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Hong Kong, Hong Kong
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Ahmeadbad, India
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Aurangabad, India
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Bangalore, India
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Chennai, India
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Hyderabad, India
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Karamsad, India
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Kochi, India
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Kolkota, India
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Lucknow, India
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Ludhiana, India
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Mangalore, India
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Manipal, India
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Mumbai, India
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Nashik, India
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New Delhi, India
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Pune, India
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Surat, India
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Visakhapatnam, India
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Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Fukuoka, Japan
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Gifu, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Kagawa, Japan
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Kanagawa, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Nagasaki, Japan
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Nigata-honmachi, Japan
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Osaka, Japan
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Shizuoka, Japan
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Tokushima, Japan
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Tokyo, Japan
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Yamagata, Japan
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Yamaguchi, Japan
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Busan, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Gyeonggi-do, South Korea
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Jeonnam, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Donostia / San Sebastian, Spain
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Leganés, Spain
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Llobregat, Spain
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Madrid, Spain
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Oviedo, Spain
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Seville, Spain
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Valencia, Spain
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Zaragoza, Spain
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Taichung, Taiwan
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Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
Related Publications (1)
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.
PMID: 30346481DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Stewart Hallett
- Organization
- SFJ Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2012
First Posted
May 16, 2012
Study Start
April 1, 2012
Primary Completion
October 10, 2017
Study Completion
May 1, 2018
Last Updated
September 20, 2019
Results First Posted
August 28, 2019
Record last verified: 2019-09