Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
|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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599754
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