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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01865747




Registration number
NCT01865747
Ethics application status
Date submitted
21/05/2013
Date registered
31/05/2013
Date last updated
27/04/2021

Titles & IDs
Public title
A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
Scientific 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 ID [1] 0 0
XL184-308
Universal Trial Number (UTN)
Trial acronym
METEOR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Cabozantinib tablets
Treatment: Drugs - Everolimus (Afinitor) tablets

Experimental: Cabozantinib (XL184) - Cabozantinib (XL184) 60 mg tablet once daily.

Active Comparator: Everolimus (Afinitor) - Everolimus (Afinitor) 10 mg tablet once daily.


Treatment: Drugs: Cabozantinib tablets


Treatment: Drugs: Everolimus (Afinitor) tablets
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
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.
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
OS was measured from the time of randomization until 320 deaths, approximately 28 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR)
Timepoint [2] 0 0
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)

Eligibility
Key inclusion criteria
Select

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2021
Sample size
Target
Accrual to date
Final
658
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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- Concord
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- Darlinghurst
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- Kogarah
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- Port Macquarie
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- Randwick
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- Box Hill
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- Wodonga
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2139 - Concord
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2010 - Darlinghurst
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3128 - Box Hill
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3690 - Wodonga
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Exelixis
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01865747
Trial related presentations / publications
Public notes

Contacts
Principal investigator
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