NCT04579679 · STUDY IN CONTEXT

Open-Label Surufatinib in European Patients With NET

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 by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

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 DCR was defined as the percentage of patients who achieved a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study.

The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.

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secondary · POSTED

Blood samples were collected at specified timepoints to obtain plasma concentrations of surufatinib at steady state on Cycle 1 Day 15.

The pharmacokinetic (PK) analysis set included all patients who received at least 1 dose of the study drug and had at least 1 measurable plasma concentration data point for at least 1 PK analyte without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at specified timepoints are reported.

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secondary · POSTED

The QT interval data was corrected for heart rate using 2 correction methods (Fridericia - QTcF and Bazett - QTcB). The treatment period was defined as the period from first administration of study drug up 30 days after last administration. msec=milliseconds, IFB=increase from baseline.

The safety analysis set included all patients who received at least 1 dose of surufatinib. Only those patients with data collected are reported.

→

secondary · POSTED

The ORR was defined as the percentage of patients with a BOR of CR or PR as determined by the Investigator using RECIST v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.

→

secondary · POSTED

The TTR was defined as the time from the start of study drug until the date of first documented objective response, either CR or PR (whichever was recorded first) according to RECIST v.1.1 for responders only. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. Only those patients who achieved CR or PR (responders) were included in the analysis.

→

secondary · POSTED

The DoR was defined as the time from the first time that the objective response reached CR or PR, whichever came first (and later confirmed), until the occurrence of PD or death. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of 1 or more new lesions was also considered progression.

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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-endocrine-carcinoma
nct id: NCT04579679
trial label: Open-Label Surufatinib in European Patients With NET
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: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0000
source section id
NCT04579679-om-0000
source outcome index
0
endpoint
Disease Control Rate (DCR)
endpoint definition
The DCR was defined as the percentage of patients who achieved a best overall response (BOR) of complete response (CR), partial response (PR) or stable disease (SD) as determined by the Investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum on study.
time origin
RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0001
source section id
NCT04579679-om-0001
source outcome index
1
endpoint
Plasma Concentrations of Surufatinib
endpoint definition
Blood samples were collected at specified timepoints to obtain plasma concentrations of surufatinib at steady state on Cycle 1 Day 15.
time origin
Cohorts A, B and C: Pre-dose and 1, 2, 3, 4 hours post-dose on Cycle 1 Day 15; Cohort D: Pre-dose and 30 minutes, 1, 2, 3, 4, 5, 6, 8 and 10 hours post-dose on Cycle 1 Day 15
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The pharmacokinetic (PK) analysis set included all patients who received at least 1 dose of the study drug and had at least 1 measurable plasma concentration data point for at least 1 PK analyte without protocol violations or events with potential to affect the PK concentration. Only those participants with data collected at specified timepoints are reported.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0002
source section id
NCT04579679-om-0002
source outcome index
2
endpoint
Number of Patients With Potentially Clinically Significant Corrected QT Interval (QTc) During Treatment
endpoint definition
The QT interval data was corrected for heart rate using 2 correction methods (Fridericia - QTcF and Bazett - QTcB). The treatment period was defined as the period from first administration of study drug up 30 days after last administration. msec=milliseconds, IFB=increase from baseline.
time origin
From the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The safety analysis set included all patients who received at least 1 dose of surufatinib. Only those patients with data collected are reported.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0003
source section id
NCT04579679-om-0003
source outcome index
3
endpoint
Objective Response Rate (ORR)
endpoint definition
The ORR was defined as the percentage of patients with a BOR of CR or PR as determined by the Investigator using RECIST v1.1. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
time origin
RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0004
source section id
NCT04579679-om-0004
source outcome index
4
endpoint
Time to Response (TTR)
endpoint definition
The TTR was defined as the time from the start of study drug until the date of first documented objective response, either CR or PR (whichever was recorded first) according to RECIST v.1.1 for responders only. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
time origin
RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. Only those patients who achieved CR or PR (responders) were included in the analysis.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0005
source section id
NCT04579679-om-0005
source outcome index
5
endpoint
Duration of Response (DOR)
endpoint definition
The DoR was defined as the time from the first time that the objective response reached CR or PR, whichever came first (and later confirmed), until the occurrence of PD or death. The CR was defined as disappearance of all target lesions. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters. The appearance of 1 or more new lesions was also considered progression.
time origin
RECIST assessments performed at screening (within 28 days before start of study drug), every 8 weeks for the first 24 weeks from C1D1, then every 12 weeks thereafter until the occurrence of disease progression, up to approximately 36 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analysis set included all patients who received at least 1 dose of surufatinib and had at least 1 post-baseline tumor assessment. Only those patients who achieved CR or PR (responders) were included in the analysis.
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-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0000
arm key
OG000
arm label
Cohort A (NET, Lung)
regimen
Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0000
arm key
OG001
arm label
Cohort B (NET, Small Bowel)
regimen
Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0000
arm key
OG002
arm label
Cohort C (NET, Other)
regimen
Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0000
arm key
OG003
arm label
Cohort D (NET, Any)
regimen
Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0000#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0001
arm key
OG000
arm label
Cohort A (NET, Lung)
regimen
Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
17
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0001
arm key
OG001
arm label
Cohort B (NET, Small Bowel)
regimen
Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0001
arm key
OG002
arm label
Cohort C (NET, Other)
regimen
Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
18
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0001
arm key
OG003
arm label
Cohort D (NET, Any)
regimen
Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0001#groups/OG003
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0002
arm key
OG000
arm label
Cohort A (NET, Lung)
regimen
Patients with NET of lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0002
arm key
OG001
arm label
Cohort B (NET, Small Bowel)
regimen
Patients with NET of small bowel origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
31
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0002
arm key
OG002
arm label
Cohort C (NET, Other)
regimen
Patients with NET of non-small bowel, non-pancreas, and non-lung origin received surufatinib 300 mg orally QD in treatment cycles of 28 days starting on C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
19
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
outcome key
om-0002
arm key
OG003
arm label
Cohort D (NET, Any)
regimen
Patients with NET of any origin received a single dose of drug cocktail (midazolam 2.5 mg, fexofenadine 30 mg and rosuvastatin 10 mg) on Day -2 followed by surufatinib 300 mg orally QD from C1D1 to C1D14. On C1D15, a single dose of surufatinib 300 mg and a single dose of drug cocktail as above was administered. Patients received surufatinib 300 mg orally QD from C1D16 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.
analyzed count
6
analyzed unit
Participants
is comparator
Source null
source pointer
NCT04579679-om-0002#groups/OG003

harms

release id
clinical-indications-draft-1
disease state id
ds-endocrine-carcinoma
nct id
NCT04579679
harm key
EG000
source section id
NCT04579679-ae
event group key
EG000
event group label
Cohort A (NET, Lung)
serious affected
4
serious at risk
20
other affected
20
other at risk
20
frequency threshold
0
collection period
Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months
event definition
The safety analysis set included all patients who received at least 1 dose of surufatinib.
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-endocrine-carcinoma
nct id
NCT04579679
harm key
EG001
source section id
NCT04579679-ae
event group key
EG001
event group label
Cohort B (NET, Small Bowel)
serious affected
12
serious at risk
32
other affected
32
other at risk
32
frequency threshold
0
collection period
Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months
event definition
The safety analysis set included all patients who received at least 1 dose of surufatinib.
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-endocrine-carcinoma
nct id
NCT04579679
harm key
EG002
source section id
NCT04579679-ae
event group key
EG002
event group label
Cohort C (NET, Other)
serious affected
8
serious at risk
20
other affected
20
other at risk
20
frequency threshold
0
collection period
Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months
event definition
The safety analysis set included all patients who received at least 1 dose of surufatinib.
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-endocrine-carcinoma
nct id
NCT04579679
harm key
EG003
source section id
NCT04579679-ae
event group key
EG003
event group label
Cohort D (NET, Any)
serious affected
2
serious at risk
6
other affected
6
other at risk
6
frequency threshold
0
collection period
Adverse events were collected from the first dose of study drug (Day 1) up to 30 days after last dose of study drug, approximately 33 months. Deaths were collected from screening (Day -28) up to end of follow-up, approximately 36 months
event definition
The safety analysis set included all patients who received at least 1 dose of surufatinib.
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