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History of Changes for Study: NCT01865747
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
Latest version (submitted April 1, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 30, 2013 None (earliest Version on record)
2 June 1, 2013 Recruitment Status, Study Status and Contacts/Locations
3 August 1, 2013 Study Status and Contacts/Locations
4 August 13, 2013 Contacts/Locations and Study Status
5 September 5, 2013 Contacts/Locations and Study Status
6 September 12, 2013 Contacts/Locations and Study Status
7 September 20, 2013 Contacts/Locations and Study Status
8 October 22, 2013 Contacts/Locations and Study Status
9 November 8, 2013 Contacts/Locations and Study Status
10 November 19, 2013 Contacts/Locations and Study Status
11 December 4, 2013 Contacts/Locations and Study Status
12 December 10, 2013 Contacts/Locations and Study Status
13 December 23, 2013 Contacts/Locations and Study Status
14 January 10, 2014 Contacts/Locations and Study Status
15 January 14, 2014 Contacts/Locations and Study Status
16 January 24, 2014 Contacts/Locations and Study Status
17 January 30, 2014 Contacts/Locations and Study Status
18 February 4, 2014 Contacts/Locations and Study Status
19 February 5, 2014 Contacts/Locations and Study Status
20 February 11, 2014 Contacts/Locations and Study Status
21 February 19, 2014 Contacts/Locations and Study Status
22 March 4, 2014 Contacts/Locations and Study Status
23 March 11, 2014 Contacts/Locations and Study Status
24 March 27, 2014 Contacts/Locations and Study Status
25 April 2, 2014 Contacts/Locations and Study Status
26 April 8, 2014 Contacts/Locations and Study Status
27 April 21, 2014 Contacts/Locations and Study Status
28 May 2, 2014 Contacts/Locations and Study Status
29 May 8, 2014 Contacts/Locations and Study Status
30 May 22, 2014 Contacts/Locations and Study Status
31 May 29, 2014 Contacts/Locations and Study Status
32 June 11, 2014 Contacts/Locations and Study Status
33 June 23, 2014 Contacts/Locations and Study Status
34 July 8, 2014 Study Status and Contacts/Locations
35 July 29, 2014 Contacts/Locations and Study Status
36 September 11, 2014 Study Status
37 September 17, 2014 Contacts/Locations and Study Status
38 October 20, 2014 Contacts/Locations and Study Status
39 November 6, 2014 Recruitment Status, Contacts/Locations and Study Status
40 April 13, 2015 Arms and Interventions and Study Status
41 July 14, 2016 Study Status
42 June 19, 2017 Study Status, Outcome Measures, Contacts/Locations, Study Design and Results
43 April 24, 2018 Study Status and Contacts/Locations
44 April 1, 2021 Recruitment Status and Study Status
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Study NCT01865747
Submitted Date:  May 30, 2013 (v1)
Open or close this module Study Identification
Unique Protocol ID: XL184-308
Brief Title: A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2013
Overall Status: Not yet recruiting
Study Start: June 2013
Primary Completion: September 2015 [Anticipated]
Study Completion: August 2016 [Anticipated]
First Submitted: May 21, 2013
First Submitted that
Met QC Criteria:		 May 30, 2013
First Posted: May 31, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:		 May 30, 2013
Last Update Posted: May 31, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Exelixis
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Renal Cell Carcinoma
Keywords: renal cell cancer
kidney
vascular endothelial growth factor receptor 2 (VEGFR2)
tyrosine kinase inhibitor
hepatocyte growth factor receptor protein (MET)
von Hippel-Lindau gene
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 3
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 650 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Cabozantinib (XL184)
Cabozantinib (XL184) administered as an oral single tablet once daily.
 Drug: Cabozantinib (XL184)
Active Comparator: Everolimus (Afinitor)
Everolimus (Afinitor) administered as an oral single tablet once daily.
 Drug: Everolimus (Afinitor)
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
Secondary Outcome Measures:
1. Overall Survival (OS)
[ Time Frame: up to 36 months ]

OS is measured from the time of randomization until death due to any cause assessed up to 36 months.
2. Objective Response Rate (ORR)
[ Time Frame: up to 17 months ]

ORR is the proportion of subjects, assessed up to 17 months, who have measurable disease at baseline and who have complete response (CR) or partial response (PR) at data cut off.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Select Inclusion Criteria:

  1. Documented histological or cytological diagnosis of renal cell cancer with a clear-cell component.
  2. Measurable disease as determined by the investigator.
  3. Must have received at least one VEGFR-targeting TKI (eg, sorafenib, sunitinib, axitinib, pazopanib or tivozanib).
  4. Recovery from toxicities related to any prior treatments, unless AE(s) are clinically nonsignificant and/or stable on supportive therapy.
  5. Adequate organ and marrow function.
  6. Sexually active fertile subjects(male and female)must agree to use medically accepted methods of contraception during the course of the study and for 4 months after the last dose of study treatment.
  7. Female subjects of childbearing potential must not be pregnant at screening.

Select Exclusion Criteria:

  1. Prior treatment with everolimus, or any other specific or selective TORC1/PI3K/AKT inhibitor (eg, temsirolimus), or cabozantinib.
  2. Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization.
  3. Receipt of any type of anticancer antibody (including investigational antibody) within 4 weeks before randomization.
  4. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
  5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery and stable for at least 3 months before randomization.
  6. Concomitant anticoagulation at therapeutic doses with oral anticoagulants or platelet inhibitors.
  7. Chronic treatment with corticosteroids or other immunosuppressive agents.
  8. Serious illness other than cancer.
  9. Major surgery within 3 months before randomization. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization.
  10. Pregnant or lactating females.
  11. Diagnosis of another malignancy within 2 years before randomization, except for superficial skin cancers, or localized, low grade tumors.
Open or close this module Contacts/Locations
Central Contact Person: Exelixis Clinical Trials
Telephone: 1-888- EXELIXIS (888-393-5494)
Email: druginfo@exelixis.com
Central Contact Backup: Backup or International
Telephone: 650-837-7400
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services