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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Exelixis
ClinicalTrials.gov Identifier:
NCT01865747
First received: May 21, 2013
Last updated: June 19, 2017
Last verified: June 2017
Results First Received: April 21, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Renal Cell Carcinoma
Interventions: Drug: Cabozantinib tablets
Drug: Everolimus (Afinitor) tablets

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
First patient enrolled: 08 August 2013, Data cut off date: 22 May 2015

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cabozantinib (XL184)

Cabozantinib (XL184) 60 mg tablet once daily.

Cabozantinib tablets

Everolimus (Afinitor)

Everolimus (Afinitor) 10 mg tablet once daily.

Everolimus (Afinitor) tablets


Participant Flow for 2 periods

Period 1:   Overall Study (ITT)
    Cabozantinib (XL184)   Everolimus (Afinitor)
STARTED [1]   330   328 
COMPLETED [2]   132 [3]   73 [4] 
NOT COMPLETED   198   255 
Adverse Event                32                31 
Clinical Deterioration                29                50 
Lack of Efficacy                3                0 
Protocol Violation                1                1 
Physician Decision                5                2 
Withdrawal by Subject                6                11 
Sponsor Decision                0                1 
Progressive Disease                122                158 
Reason Not Provided                0                1 
[1] Randomized
[2] Continuing study treatment at the time of data cut-off
[3] One subject randomized to everolimus arm received cabozantinib discontd due to clin. deterioration
[4] Five subjects were randomized but not treated

Period 2:   Primary Intent to Treat (PITT)
    Cabozantinib (XL184)   Everolimus (Afinitor)
STARTED [1]   187   188 [2] 
COMPLETED [3]   56   36 
NOT COMPLETED   131   152 
Adverse Event                21                20 
Clinical Deterioration                18                29 
Lack of Efficacy                2                0 
Protocol Violation                1                1 
Physician Decision                4                2 
Withdrawal by Subject                3                7 
Progressive Disease                82                92 
Other                0                1 
[1] PITT population consisted of the first 375 subjects randomized to received study treatment.
[2] Three subjects in the everolimus arm were randomized but not treated.
[3] Continuing study treatment at the time of data cut-off



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cabozantinib (XL184)

Cabozantinib (XL184) 60 mg tablet once daily.

Cabozantinib tablets

Everolimus (Afinitor)

Everolimus (Afinitor) 10 mg tablet once daily.

Everolimus (Afinitor) tablets

Total Total of all reporting groups

Baseline Measures
   Cabozantinib (XL184)   Everolimus (Afinitor)   Total 
Overall Participants Analyzed 
[Units: Participants]
 330   328   658 
Age, Customized 
[Units: Participants]
     
<65   196   198   394 
65 to <75   107   94   201 
75 to <85   26   36   62 
=>85   1   0   1 
Sex/Gender, Customized 
[Units: Participants]
     
Male   253   241   494 
Female   77   86   163 
Missing   0   1   1 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Ethnicity       
Hispanic or Latino      19   5.8%      18   5.5%      37   5.6% 
Not Hispanic or Latino      278  84.2%      273  83.2%      551  83.7% 
Unknown or Not Reported      33  10.0%      37  11.3%      70  10.6% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      21   6.4%      26   7.9%      47   7.1% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      6   1.8%      3   0.9%      9   1.4% 
White      269  81.5%      263  80.2%      532  80.9% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      34  10.3%      36  11.0%      70  10.6% 
Geographic Region 
[Units: Participants]
Count of Participants
     
Europe   167   153   320 
North America   118   122   240 
Asia Pacific   39   47   86 
Latin America   6   6   12 
Randomization Stratification Factors per CRF 
[Units: Participants]
Count of Participants
     
Prior VEGFR-TKI = 1   235   229   464 
Prior VEGFR-TKI ≥ 2   95   99   194 
MSKCC risk factors = 0   150   150   300 
MSKCC risk factors = 1   139   135   274 
MSKCC risk factors = 2 or 3   41   43   84 
Prior VEGFR-TKI = 1, MSKCC risk factors = 0   102   100   202 
Prior VEGFR-TKI = 1, MSKCC risk factors = 1   107   103   210 
Prior VEGFR-TKI = 1, MSKCC risk factors = 2 or 3   26   26   52 
Prior VEGFR-TKI ≥ 2, MSKCC risk factors =0   48   50   98 
Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 1   32   32   64 
Prior VEGFR-TKI ≥ 2, MSKCC risk factors = 2 or 3   15   17   32 
Karnofsky performance status (KPS) 
[Units: Participants]
Count of Participants
     
100 (normal activity)   99   74   173 
90 (normal activity, minor signs and symptoms)   127   142   269 
80 (normal w/effort, minor signs/symptoms)   75   90   165 
70 (unable to work, cares for self)   29   22   51 
Heng Prognostic Criteria 
[Units: Participants]
Count of Participants
     
0 adverse factors (favorable risk)   66   62   128 
1-2 adverse factors (intermediate risk)   210   214   424 
3-6 adverse factors (poor risk)   54   52   106 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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. ]

2.  Secondary:   Overall Survival (OS)   [ Time Frame: OS was measured from the time of randomization until 320 deaths, approximately 28 months ]

3.  Secondary:   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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Exelixis Medical Information
Organization: Exelixis, Inc.
phone: 855-292-3935
e-mail: druginfo@exelixis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Exelixis
ClinicalTrials.gov Identifier: NCT01865747     History of Changes
Other Study ID Numbers: XL184-308
Study First Received: May 21, 2013
Results First Received: April 21, 2017
Last Updated: June 19, 2017