Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- Disease Free Survival (DFS) [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||May 2019|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Axitinib 5 mg twice daily
Other Name: Inlyta
|Placebo Comparator: Placebo||
Placebo twice daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01599754
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