NCT03690388 · STUDY IN CONTEXT

A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Fact

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

Time to the earlier of either radiographic progressive disease (PD) or death from any cause.

All subjects randomized at the time of the analysis (N=187).

→

primary · POSTED

Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).

The first 100 subjects randomized.

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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-thyroid-cancer
nct id: NCT03690388
trial label: A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth Fact
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: 2
harms Count: 2
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT03690388
outcome key
om-0000
source section id
NCT03690388-om-0000
source outcome index
0
endpoint
Progression Free Survival (PFS)
endpoint definition
Time to the earlier of either radiographic progressive disease (PD) or death from any cause.
time origin
Up to approximately twenty months after the first subject is randomized. Time from randomization to the earlier of the following events: radiographic PD as determined by the blinded independent central review (BIRC) or death due to any cause.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All subjects randomized at the time of the analysis (N=187).
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-thyroid-cancer
nct id
NCT03690388
outcome key
om-0001
source section id
NCT03690388-om-0001
source outcome index
1
endpoint
Objective Response Rate (ORR)
endpoint definition
Proportion of subjects with the best overall response of complete response (CR) or partial response (PR).
time origin
Six months after 100 subjects are randomized. Time from randomization to best overall response of confirmed complete response (CR) or confirmed partial response (PR) per BIRC per RECIST 1.1.
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The first 100 subjects randomized.
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-thyroid-cancer
nct id
NCT03690388
outcome key
om-0000
arm key
OG000
arm label
Cabozantinib
regimen
cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
analyzed count
125
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03690388-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT03690388
outcome key
om-0000
arm key
OG001
arm label
Placebo
regimen
placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
analyzed count
62
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03690388-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT03690388
outcome key
om-0001
arm key
OG000
arm label
Cabozantinib
regimen
cabozantinib (60 mg) once daily orally (qd) Cabozantinib: Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
analyzed count
67
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03690388-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT03690388
outcome key
om-0001
arm key
OG001
arm label
Placebo
regimen
placebo once daily orally (qd) Placebo: Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
analyzed count
33
analyzed unit
Participants
is comparator
Source null
source pointer
NCT03690388-om-0001#groups/OG001

harms

release id
clinical-indications-draft-1
disease state id
ds-thyroid-cancer
nct id
NCT03690388
harm key
EG000
source section id
NCT03690388-ae
event group key
EG000
event group label
Cabozantinib
serious affected
43
serious at risk
125
other affected
112
other at risk
125
frequency threshold
5
collection period
1 year, 8 months.
event definition
Safety assessments included evaluations of AEs, SAEs, deaths, clinical laboratory test results (hematology, serum chemistry, and urinalysis), physical examination findings, vital sign measurements, Eastern Cooperative Oncology Group performance status (ECOG PS), and 12-lead ECG recordings.
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-thyroid-cancer
nct id
NCT03690388
harm key
EG001
source section id
NCT03690388-ae
event group key
EG001
event group label
Placebo
serious affected
18
serious at risk
62
other affected
32
other at risk
62
frequency threshold
5
collection period
1 year, 8 months.
event definition
Safety assessments included evaluations of AEs, SAEs, deaths, clinical laboratory test results (hematology, serum chemistry, and urinalysis), physical examination findings, vital sign measurements, Eastern Cooperative Oncology Group performance status (ECOG PS), and 12-lead ECG recordings.
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