Clear Cell Renal CarcinomaPhase 3ATLASNCT01599754
Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients
A Phase 3 study testing Axitinib in people with Clear Cell Renal Carcinoma, run by SFJ Pharma Ltd. II at 106 sites in 9 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Carcinoma
- What is being tested?
- Axitinib
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 724 participants
- Where
- 106 sitesin 9 countries
- Study dates
- Apr 2012to May 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- 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
Show all 12Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
106 sites in 9 countries.
106 sites in 9 countries
United States26 sites
Study site
Albany, New York, 12208
Study site
Annapolis, Maryland, 21403
Study site
Atlanta, Georgia, 30322
Study site
Austin, Texas, 78731
Study site
Baltimore, Maryland, 21231-1000
Study site
Bedford, Texas, 76022
Study site
Charleston, South Carolina, 29412
Study site
Chattanooga, Tennessee, 37421
Study site
Dallas, Texas, 75203
Study site
Denver, Colorado, 80218
Study site
Hackensack, New Jersey, 07601
Study site
Houston, Texas, 77024
Study site
La Jolla, California, 92093
Study site
Los Angeles, California, 90033
Study site
New York, New York, 10467
Study site
Norfolk, Virginia, 23502
Study site
Ocala, Florida, 34471
Study site
Omaha, Nebraska, 68198
Study site
Palo Alto, California, 94304
Study site
Pleasant Hill, California, 94523
Study site
Portland, Oregon, 97227
Study site
Saint Paul, Minnesota, 55118
Study site
San Antonio, Texas, 78217
Study site
San Antonio, Texas, 78234
Study site
Seattle, Washington, 95109
Study site
Washington D.C., District of Columbia, 20007
Japan20 sites
Study site
Aichi
Study site
Akita
Study site
Aomori
Study site
Chiba
Study site
Fukuoka
Study site
Gifu
Study site
Hokkaido
Study site
Hyōgo
Study site
Kagawa
Study site
Kanagawa
Study site
Kumamoto
Study site
Kyoto
Study site
Nagasaki
Study site
Nigata-honmachi
Study site
Osaka
Study site
Shizuoka
Study site
Tokushima
Study site
Tokyo
Study site
Yamagata
Study site
Yamaguchi
India18 sites
Study site
Ahmeadbad
Study site
Bangalore
Study site
Chennai
Study site
Chhatrapati Sambhajinagar
Study site
Hyderabad
Study site
Karamsad
Study site
Kochi
Study site
Kolkota
Study site
Lucknow
Study site
Ludhiana
Study site
Mangalore
Study site
Manipal
Study site
Mumbai
Study site
Nashik
Study site
New Delhi
Study site
Pune
Study site
Surat
Study site
Visakhapatnam
China12 sites
Study site
Beijing
Study site
Changchun
Study site
Chongqing
Study site
Dalian
Study site
Guangzhou
Study site
Hangzhou
Study site
Jinan
Study site
Nanchang
Study site
Shanghai
Study site
Suzhou
Study site
Tianjin
Study site
Wuhan
France11 sites
Study site
Besançon
Study site
Bordeaux
Study site
Hyères
Study site
Le Mans
Study site
Lyon
Study site
Marseille
Study site
Paris
Study site
Rennes
Study site
Saint-Herblain
Study site
Suresnes
Study site
Vandœuvre-lès-Nancy
Spain9 sites
Study site
Barcelona
Study site
Donostia / San Sebastian
Study site
Leganés
Study site
Llobregat
Study site
Madrid
Study site
Oviedo
Study site
Seville
Study site
Valencia
Study site
Zaragoza
South Korea6 sites
Study site
Busan
Study site
Daegu
Study site
Daejeon
Study site
Gyeonggi-do
Study site
Jeonnam
Study site
Seoul
About this study
Official title: 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
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.
Read the detailed description
This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.
Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
- Conditions
- Clear Cell Renal Carcinoma
- Being tested
- Axitinib, Placebo
- Keywords
- renal cell carcinoma, axitinib, tyrosine kinase inhibitor
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AxitinibDrug
Also called Inlyta
Axitinib 5 mg twice daily
PlaceboDrug
Placebo twice daily
| Study group | Role | What they receive |
|---|---|---|
| Axitinib | Experimental | Not described Receives: Drug: Axitinib |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
OS defined as the time from the date of randomization to the date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Participants lacking data beyond randomization had their survival times censored at randomization.
Measured: 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)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AEs included both serious and non-serious adverse events.
Measured: 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)
A treatment related AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event had a causal relationship with the treatment or usage. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness was judged by investigator. AEs included both serious and non-serious adverse events.
Measured: 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
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. AE was assessed according to severity as: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Measured: 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
Hematology parameters included anemia, hemoglobin increased, lymphocyte count increased, lymphocyte count decreased, neutrophil count decreased, platelet count decreased, and white blood cell count decreased. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Measured: 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: Chemistry
Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, creatine phosphokinase increased, creatinine increased, hypoalbuminemia, hypercalcemia, hypocalcemia, hyperglycemia, hypoglycemia, hyperkalemia, hypokalemia, hypernatremia, hyponatremia. CTCAE grades: Grade 1 (mild AE), Grade 2 (moderate AE), Grade 3 (severe AE), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).
Measured: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Thyroid Function
Number of participants with thyrotropin levels: <5 milli-international units per litre (mIU/L), >=5 to <10 mIU/L, >=10 mIU/L are reported.
Measured: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Urinalysis
Number of participants with urine protein dipstick grading: negative/trace (5 to 20 milligram per deciliter [mg/dL]), 1+ (30 mg/dL]), 2+ (100 mg/dL), 3+ (300 mg/dL) and 4+ (more than 1000 mg/dL) are reported.
Measured: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study startApr 2012
- Primary completion10 Oct 2017
- Study completionMay 2018
Why it stopped: Primary endpoint did not reach statistical significance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Cell Renal CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 724 participants (actual)
Sponsor and investigators
- Lead sponsor
- SFJ Pharma Ltd. II
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pfizer, SFJ Pharmaceuticals, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01599754
- Sponsor's protocol ID
- AP311736
- Acronym
- ATLAS
- Status last verified
- Sep 2019
- First submitted
- 11 May 2012
- Last updated
- 20 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 30346481
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01599754
- Acronym / sponsor ID
- ATLAS / AP311736
- Conditions
- Clear Cell Renal Carcinoma
- Keywords
- renal cell carcinoma, axitinib, tyrosine kinase inhibitor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Primary endpoint did not reach statistical significance
- Enrolment
- 724 participants (actual)
- Lead sponsor
- SFJ Pharma Ltd. IIIndustry (pharma, biotech, devices)
- Collaborators
- Pfizer, SFJ Pharmaceuticals, Inc.
- Study start
- Apr 2012
- Primary completion
- 10 Oct 2017 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 16 May 2012 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, randomized, double blind placebo controlled Phase 3 trial of oral axitinib starting at 5 mg twice daily given 3 years vs. placebo.
Approximately 700 patients will be randomized in a 1:1 ratio between axitinib vs placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Axitinib | Experimental | Drug: Axitinib |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must be treated by nephrectomy and patients must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
- 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):
- Patients must have histologically confirmed preponderant, defined as >50%, clear cell RCC.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AxitinibAlso: InlytaAxitinib 5 mg twice daily | Drug | Axitinib |
| PlaceboPlacebo twice daily | Drug | Placebo |
Primary outcome
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC)
Time frame: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)
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.
8 secondary outcomes
Overall Survival (OS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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: Chemistry
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Thyroid Function
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Number of Participants With Laboratory Abnormalities: Urinalysis
Time frame: From Day 1 up to 28 days after last dose (maximum duration of 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30346481Gross-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
106 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Axitinib in people with Clear Cell Renal Carcinoma, run by SFJ Pharma Ltd. II at 106 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 106 sites in United States, Japan, India, China, France and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) as Assessed by Blinded Independent Review Committee (IRC) (time frame: From randomization date up to first date of recurrence or the occurrence of a secondary malignancy or death (up to 5 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01599754, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.