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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
Axitinib 5 mg twice daily
Other Name: Inlyta
|Placebo Comparator: 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.
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
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