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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

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.

The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).

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secondary · POSTED

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).

The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.

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secondary · POSTED

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.

The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-renal-cell-cancer-jobevne-9feed5d7
nct id: NCT01865747
trial label: A Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 3
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0000
source section id
NCT01865747-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS)
endpoint definition
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.
time origin
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.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The pre-specified primary analysis of PFS was based on the first 375 randomized subjects (187 cabozantinib and 188 everolimus).
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0001
source section id
NCT01865747-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
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).
time origin
OS was measured from the time of randomization until 320 deaths, approximately 28 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The Intent to Treat (ITT) population was used and included 658 randomized subjects (330 cabozantinib, 328 everolimus) in the second interim analysis with a cutoff date of 31 December 2015.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0002
source section id
NCT01865747-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR)
endpoint definition
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.
time origin
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)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The analysis of ORR was performed in the ITT population (all randomized: 330 cabozantinib, 328 everolimus) based upon response determined by Independent Radiology Committee (IRC) per RECIST 1.1.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0000
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
analyzed count
187
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0000
arm key
OG001
arm label
Everolimus (Afinitor)
regimen
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
analyzed count
188
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0001
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
analyzed count
330
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0001
arm key
OG001
arm label
Everolimus (Afinitor)
regimen
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
analyzed count
228
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0002
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily. Cabozantinib tablets
analyzed count
330
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
outcome key
om-0002
arm key
OG001
arm label
Everolimus (Afinitor)
regimen
Everolimus (Afinitor) 10 mg tablet once daily. Everolimus (Afinitor) tablets
analyzed count
328
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01865747-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
harm key
EG000
source section id
NCT01865747-ae
event group key
EG000
event group label
Cabozantinib (XL184)
serious affected
131
serious at risk
331
other affected
328
other at risk
331
frequency threshold
5
collection period
08 August 2013 - 22 May 2015
event definition
The safety data includes subjects who were randomized and treated. Of 658 patients, 330 were randomized to receive cabozantinib and 328 everolimus. Five subjects in the everolimus arm were randomized but not treated. One subject randomized to the everolimus arm received cabozantinib only as study treatment and was evaluated in the cabozantinib arm for the Safety population (331 cabozantinib, 322 everolimus).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-renal-cell-cancer-jobevne-9feed5d7
nct id
NCT01865747
harm key
EG001
source section id
NCT01865747-ae
event group key
EG001
event group label
Everolimus (Afinitor)
serious affected
139
serious at risk
322
other affected
270
other at risk
322
frequency threshold
5
collection period
08 August 2013 - 22 May 2015
event definition
The safety data includes subjects who were randomized and treated. Of 658 patients, 330 were randomized to receive cabozantinib and 328 everolimus. Five subjects in the everolimus arm were randomized but not treated. One subject randomized to the everolimus arm received cabozantinib only as study treatment and was evaluated in the cabozantinib arm for the Safety population (331 cabozantinib, 322 everolimus).
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice