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A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma (METEOR)

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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:
Information provided by (Responsible Party):
Exelixis

Study Description
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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.

Condition or disease Intervention/treatment Phase
Renal Cell Carcinoma Drug: Cabozantinib tablets Drug: Everolimus (Afinitor) tablets Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 658 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Completion Date : January 15, 2021

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865747


Locations
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Sponsors and Collaborators
Exelixis
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01865747    
Other Study ID Numbers: XL184-308
First Posted: May 31, 2013    Key Record Dates
Results First Posted: July 18, 2017
Last Update Posted: April 27, 2021
Last Verified: April 2021
Keywords provided by Exelixis:
renal cell cancer
kidney
vascular endothelial growth factor receptor 2 (VEGFR2)
 tyrosine kinase inhibitor
hepatocyte growth factor receptor protein (MET)
von Hippel-Lindau gene
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Kidney Diseases
Urologic Diseases
Male Urogenital Diseases
Everolimus
MTOR Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents