NCT01908426 · STUDY IN CONTEXT

Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib

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

The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.

The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017.

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secondary · POSTED

Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.

The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo).

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secondary · POSTED

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

The analysis of ORR was performed in the ITT population (all randomized: 470 cabozantinib, 237 placebo) based upon response determined by Investigator 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-liver-neoplasm
nct id: NCT01908426
trial label: Study of Cabozantinib (XL184) vs Placebo in Subjects With Hepatocellular Carcinoma Who Have Received Prior Sorafenib
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-liver-neoplasm
nct id
NCT01908426
outcome key
om-0000
source section id
NCT01908426-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
The primary analysis of OS is defined as the time from randomization to death from any cause. The analysis was based on a second planned interim analysis prespecified to be performed at approximately the 75% information fraction (ie, at approximately 466 deaths). The data cutoff date for this event-driven analysis in the Intent to Treat (ITT) population was 01 June 2017. Median OS was calculated using the Kaplan-Meier estimates.
time origin
Up to 45 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The ITT population was used and included 707 randomized subjects (470 cabozantinib, 237 placebo) in the second interim analysis with a cutoff date of 01 June 2017.
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-liver-neoplasm
nct id
NCT01908426
outcome key
om-0001
source section id
NCT01908426-om-0001
source outcome index
1
endpoint
Progression-Free Survival (PFS)
endpoint definition
Duration of PFS is defined as the time of randomization to the earlier of the following events, progressive disease as determined by Investigator (per RECIST 1.0, which is defined by a ≥ 20% increase in the sum of the longest diameter of target lesions from baseline) or death due to any cause. A Kaplan- Meier analysis was performed to estimate the median duration.
time origin
Up to 45 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The prespecified primary analysis of PFS was based on the first 707 randomized subjects (470 cabozantinib, 237 placebo).
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-liver-neoplasm
nct id
NCT01908426
outcome key
om-0002
source section id
NCT01908426-om-0002
source outcome index
2
endpoint
Objective Response Rate (ORR)
endpoint definition
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
time origin
ORR is measured by radiologic assessment every 8 weeks after randomization until disease progression or discontinuation of study treatment (up to 45 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: 470 cabozantinib, 237 placebo) based upon response determined by Investigator 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-liver-neoplasm
nct id
NCT01908426
outcome key
om-0000
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
analyzed count
470
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
analyzed count
237
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
outcome key
om-0001
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
analyzed count
470
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
analyzed count
237
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
outcome key
om-0002
arm key
OG000
arm label
Cabozantinib (XL184)
regimen
Cabozantinib (XL184) 60 mg tablet once daily Cabozantinib tablets
analyzed count
470
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
outcome key
om-0002
arm key
OG001
arm label
Placebo
regimen
Oral cabozantinib-matched placebo tablet once daily Placebo tablets
analyzed count
237
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01908426-om-0002#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT01908426
harm key
EG000
source section id
NCT01908426-ae
event group key
EG000
event group label
Cabozantinib (XL184)
serious affected
232
serious at risk
467
other affected
445
other at risk
467
frequency threshold
5
collection period
Up to 61 weeks
event definition
The safety data includes subjects who were randomized and treated. Of 707 patients, 470 were randomized to received cabozantinib and 237 to placebo. Three subjects in the cabozantinib arm were randomized but did not receive study drug. Thus, a total of 704 subjects received study treatment in the Safety Population (467 cabozantinib, 237 placebo).
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-liver-neoplasm
nct id
NCT01908426
harm key
EG001
source section id
NCT01908426-ae
event group key
EG001
event group label
Placebo
serious affected
87
serious at risk
237
other affected
173
other at risk
237
frequency threshold
5
collection period
Up to 61 weeks
event definition
The safety data includes subjects who were randomized and treated. Of 707 patients, 470 were randomized to received cabozantinib and 237 to placebo. Three subjects in the cabozantinib arm were randomized but did not receive study drug. Thus, a total of 704 subjects received study treatment in the Safety Population (467 cabozantinib, 237 placebo).
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