A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
|ClinicalTrials.gov Identifier: NCT01865747|
Recruitment Status : Active, not recruiting
First Posted : May 31, 2013
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma||Drug: Cabozantinib tablets Drug: Everolimus (Afinitor) tablets||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||658 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 22, 2015|
|Estimated Study Completion Date :||December 2017|
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) 60 mg tablet once daily.
Drug: Cabozantinib tablets
Other Name: XL184
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) 10 mg tablet once daily.
|Drug: Everolimus (Afinitor) tablets|
- Progression-free Survival (PFS) [ Time Frame: PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause as determined by the Independent Radiology Committee (IRC) per RECIST 1.1, assessed for up to 17 months. ]The primary analysis of PFS is the time from randomization to date of first documented tumor progression as determined by investigator (per RECIST 1.1 criteria) or death due to any cause, whichever occurred first. A Kaplan-Meier analysis was performed to estimate the median duration.
- Overall Survival (OS) [ Time Frame: OS was measured from the time of randomization until 320 deaths, approximately 28 months ]Overall Survival (OS) is defined as the time from randomization to the date of death. Participants that had not died were censored at last known date alive. Median OS was calculated using Kaplan-Meier estimates. Interim analyses for OS occurred after 320 deaths (78% of the total OS events needed for final analysis).
- Objective Response Rate (ORR) [ Time Frame: ORR was assessed at 8 weeks post-randomization, every 8 weeks for 12 months, and every 12 weeks until date of disease progression or death, up to May 2015 (approximately 21 months) ]Objective Response Rate (ORR) is the number of participants with a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. ORR was assessed by the Independent Radiology Committee (IRC) per RECIST 1.1 which was confirmed by a subsequent visit >= 28 days later, and was analyzed in the Intent to Treat (ITT) population at the time of the primary analysis of Progression Free Survival (PFS). The data cutoff date was 22 May 2015.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865747
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