NCT01835158 · STUDY IN CONTEXT

Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published

All patients that were enrolled on to study.

→

primary · POSTED

The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.

All enrolled patients

→

secondary · POSTED

Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.

All enrolled patients.

→

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-clear-cell-adenocarcinoma
nct id: NCT01835158
trial label: Cabozantinib-s-malate or Sunitinib Malate in Treating Patients With Previously Untreated Locally Advanced or Metastatic Kidney Cancer
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0000
source section id
NCT01835158-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
Progression free survival (PFS) was investigator assessed and is measured from the beginning of treatment until patient progression or death. Progression was determined using RECIST 1.1 criteria, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on PFS. The Kaplan-Meier product-limit estimator will be used to estimate PFS distributions.Progression Free Survival was assessed per investigator, as this was the protocol-specified endpoint, and both investigator and independent review analyses of the PFS endpoint have been published
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All patients that were enrolled on to study.
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-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0001
source section id
NCT01835158-om-0001
source outcome index
1
endpoint
Overall Survival (OS)
endpoint definition
The primary analysis will be based on the stratified log-rank statistic to compare the two treatment arms on OS. The Kaplan-Meier product-limit estimator will be used to estimate OS distributions.
time origin
Up to 5 years
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled patients
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-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0002
source section id
NCT01835158-om-0002
source outcome index
2
endpoint
Objective Response Rates
endpoint definition
Objective response rates (ORR) was investigator assessed. ORR is the rate of complete or partial responses, based on RECIST 1.1 criteria. A response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. The Fisher exact test will be used to compare the two treatment arms.
time origin
Up to 5 years
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All enrolled patients.
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-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0000
arm key
OG000
arm label
Arm I (Cabozantinib-s-malate)
regimen
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0000
arm key
OG001
arm label
Arm II (Sunitinib Malate)
regimen
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0001
arm key
OG000
arm label
Arm I (Cabozantinib-s-malate)
regimen
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0001
arm key
OG001
arm label
Arm II (Sunitinib Malate)
regimen
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0002
arm key
OG000
arm label
Arm I (Cabozantinib-s-malate)
regimen
Patients receive 60mg cabozantinib-s-malate PO QD for 6 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
79
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
outcome key
om-0002
arm key
OG001
arm label
Arm II (Sunitinib Malate)
regimen
Patients receive 50mg sunitinib malate PO QD for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
analyzed count
78
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01835158-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-clear-cell-adenocarcinoma
nct id
NCT01835158
harm key
EG000
source section id
NCT01835158-ae
event group key
EG000
event group label
Arm I (Cabozantinib-s-malate)
serious affected
39
serious at risk
78
other affected
76
other at risk
78
frequency threshold
0
collection period
Source null
event definition
Source null
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-clear-cell-adenocarcinoma
nct id
NCT01835158
harm key
EG001
source section id
NCT01835158-ae
event group key
EG001
event group label
Arm II (Sunitinib Malate)
serious affected
39
serious at risk
72
other affected
68
other at risk
72
frequency threshold
0
collection period
Source null
event definition
Source null
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