Adjuvant Axitinib Therapy of Renal Cell Cancer in High Risk Patients (ATLAS)
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.
|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
|Contact: Rolf Linke, MDemail@example.com|
|Contact: Stewart Hallettfirstname.lastname@example.org|
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