Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
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ClinicalTrials.gov Identifier: NCT01599754 |
Recruitment Status :
Terminated
(Primary endpoint did not reach statistical significance)
First Posted : May 16, 2012
Last Update Posted : May 10, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clear Cell Renal Carcinoma | Drug: Axitinib Drug: Placebo | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 722 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | April 2012 |
Actual Primary Completion Date : | March 2018 |
Actual Study Completion Date : | May 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Axitinib |
Drug: Axitinib
Axitinib 5 mg twice daily
Other Name: Inlyta |
Placebo Comparator: Placebo |
Drug: Placebo
Placebo twice daily |
- Disease Free Survival (DFS) [ Time Frame: 5 years ]To demonstrate an improvement in disease free survival (DFS) in patients at high risk of recurrent RCC randomly assigned to adjuvant axitinib (Arm A) vs. Placebo (Arm B) after nephrectomy.
- Overall Survival (OS) [ Time Frame: 5 years ]Compare Overall Survival (OS) associated with Arm A to that associated with Arm B. OS defined as the time from the date of randomization to the date of death due to any cause.
- Safety [ Time Frame: 5 years ]Assess safety profile of Arm A to Arm B. Assessment of adverse events will include: type, incidence, severity (graded by the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], Version 4.0), timing, seriousness, and relatedness; and laboratory abnormalities.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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
- 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.
Exclusion Criteria
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599754

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | SFJ Pharma Ltd. II |
ClinicalTrials.gov Identifier: | NCT01599754 History of Changes |
Other Study ID Numbers: |
AP311736 |
First Posted: | May 16, 2012 Key Record Dates |
Last Update Posted: | May 10, 2018 |
Last Verified: | May 2018 |
Keywords provided by SFJ Pharmaceuticals, Inc. ( SFJ Pharma Ltd. II ):
renal cell carcinoma axitinib tyrosine kinase inhibitor |
Additional relevant MeSH terms:
Carcinoma, Renal Cell Kidney Neoplasms Carcinoma Kidney Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Urologic Diseases Axitinib Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |