A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01865747 |
Recruitment Status :
Completed
First Posted : May 31, 2013
Results First Posted : July 18, 2017
Last Update Posted : April 27, 2021
|
Sponsor:
Exelixis
Information provided by (Responsible Party):
Exelixis
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Tracking Information | |||
---|---|---|---|
First Submitted Date ICMJE | May 21, 2013 | ||
First Posted Date ICMJE | May 31, 2013 | ||
Results First Submitted Date ICMJE | April 21, 2017 | ||
Results First Posted Date ICMJE | July 18, 2017 | ||
Last Update Posted Date | April 27, 2021 | ||
Study Start Date ICMJE | June 2013 | ||
Actual Primary Completion Date | May 22, 2015 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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.
|
||
Original Primary Outcome Measures ICMJE |
Progression-free survival (PFS) [ Time Frame: up to 17 months ] PFS is measured from the date of randomization until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed for up to 17 months.
|
||
Change History | |||
Current Secondary Outcome Measures ICMJE |
|
||
Original Secondary Outcome Measures ICMJE |
|
||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma | ||
Official Title ICMJE | 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 | ||
Brief Summary | The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy. | ||
Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||
Condition ICMJE | Renal Cell Carcinoma | ||
Intervention ICMJE |
|
||
Study Arms ICMJE |
|
||
Publications * |
|
||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||
Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
658 | ||
Original Estimated Enrollment ICMJE |
650 | ||
Actual Study Completion Date ICMJE | January 15, 2021 | ||
Actual Primary Completion Date | May 22, 2015 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Select Inclusion Criteria:
Select Exclusion Criteria:
|
||
Sex/Gender ICMJE |
|
||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Korea, Republic of, Netherlands, Poland, Portugal, Russian Federation, Slovakia, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States | ||
Removed Location Countries | Brazil, Czech Republic | ||
Administrative Information | |||
NCT Number ICMJE | NCT01865747 | ||
Other Study ID Numbers ICMJE | XL184-308 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Current Responsible Party | Exelixis | ||
Original Responsible Party | Same as current | ||
Current Study Sponsor ICMJE | Exelixis | ||
Original Study Sponsor ICMJE | Same as current | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Exelixis | ||
Verification Date | April 2021 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |