NCT04579679 · OUTCOME
Plasma Concentrations of Surufatinib
Open-Label Surufatinib in European Patients With NET · Source last updated 2025-07-25
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- nanogram/milliliter
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- 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
What was measured
Blood samples were collected at specified timepoints to obtain plasma concentrations of surufatinib at steady state on Cycle 1 Day 15.
Analysis population: 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.
Groups in this outcome
Cohort A (NET, Lung)
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.
Cohort B (NET, Small Bowel)
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.
Cohort C (NET, Other)
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.
Cohort D (NET, Any)
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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 29 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Reported measurements
Pre-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 25 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 73.123 | 70.1 | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 57.593 | 136.8 | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 49.258 | 54.7 | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 28.913 | 130.5 | Not reported | Not reported | Not reported |
|---|
30 minutes post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 0 |
|---|
| Cohort B (NET, Small Bowel) | 0 |
|---|
| Cohort C (NET, Other) | 0 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D (NET, Any) | 50.439 | 190.5 | Not reported | Not reported | Not reported |
|---|
1 hour post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 29 |
|---|
| Cohort C (NET, Other) | 15 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 130.456 | 118.3 | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 96.163 | 115.2 | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 101.464 | 125.6 | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 129.719 | 303.6 | Not reported | Not reported | Not reported |
|---|
2 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 27 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 234.498 | 122.1 | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 174.799 | 138.1 | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 194.654 | 80.5 | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 321.942 | 99.9 | Not reported | Not reported | Not reported |
|---|
3 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 29 |
|---|
| Cohort C (NET, Other) | 18 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 287.237 | 95.0 | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 250.348 | 101.8 | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 245.379 | 55.1 | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 477.653 | 118.6 | Not reported | Not reported | Not reported |
|---|
4 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 17 |
|---|
| Cohort B (NET, Small Bowel) | 28 |
|---|
| Cohort C (NET, Other) | 17 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A (NET, Lung) | 293.236 | 85.6 | Not reported | Not reported | Not reported |
|---|
| Cohort B (NET, Small Bowel) | 268.619 | 65.9 | Not reported | Not reported | Not reported |
|---|
| Cohort C (NET, Other) | 232.657 | 42.6 | Not reported | Not reported | Not reported |
|---|
| Cohort D (NET, Any) | 389.597 | 102.8 | Not reported | Not reported | Not reported |
|---|
5 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 0 |
|---|
| Cohort B (NET, Small Bowel) | 0 |
|---|
| Cohort C (NET, Other) | 0 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D (NET, Any) | 357.045 | 105.4 | Not reported | Not reported | Not reported |
|---|
6 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 0 |
|---|
| Cohort B (NET, Small Bowel) | 0 |
|---|
| Cohort C (NET, Other) | 0 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D (NET, Any) | 280.691 | 105.2 | Not reported | Not reported | Not reported |
|---|
8 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 0 |
|---|
| Cohort B (NET, Small Bowel) | 0 |
|---|
| Cohort C (NET, Other) | 0 |
|---|
| Cohort D (NET, Any) | 6 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D (NET, Any) | 202.345 | 102.7 | Not reported | Not reported | Not reported |
|---|
10 hours post-dose
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A (NET, Lung) | 0 |
|---|
| Cohort B (NET, Small Bowel) | 0 |
|---|
| Cohort C (NET, Other) | 0 |
|---|
| Cohort D (NET, Any) | 4 |
|---|
Values in nanogram/milliliter · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort D (NET, Any) | 174.079 | 84.1 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 70.1
- value
- 73.123
- group Id
- OG001
- spread
- 136.8
- value
- 57.593
- group Id
- OG002
- spread
- 54.7
- value
- 49.258
- group Id
- OG003
- spread
- 130.5
- value
- 28.913
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 25
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- Pre-dose
- categories
- measurements
- group Id
- OG003
- spread
- 190.5
- value
- 50.439
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 30 minutes post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 118.3
- value
- 130.456
- group Id
- OG001
- spread
- 115.2
- value
- 96.163
- group Id
- OG002
- spread
- 125.6
- value
- 101.464
- group Id
- OG003
- spread
- 303.6
- value
- 129.719
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 1 hour post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 122.1
- value
- 234.498
- group Id
- OG001
- spread
- 138.1
- value
- 174.799
- group Id
- OG002
- spread
- 80.5
- value
- 194.654
- group Id
- OG003
- spread
- 99.9
- value
- 321.942
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 27
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 2 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 95.0
- value
- 287.237
- group Id
- OG001
- spread
- 101.8
- value
- 250.348
- group Id
- OG002
- spread
- 55.1
- value
- 245.379
- group Id
- OG003
- spread
- 118.6
- value
- 477.653
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 3 hours post-dose
- categories
- measurements
- group Id
- OG000
- spread
- 85.6
- value
- 293.236
- group Id
- OG001
- spread
- 65.9
- value
- 268.619
- group Id
- OG002
- spread
- 42.6
- value
- 232.657
- group Id
- OG003
- spread
- 102.8
- value
- 389.597
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 28
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 4 hours post-dose
- categories
- measurements
- group Id
- OG003
- spread
- 105.4
- value
- 357.045
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 5 hours post-dose
- categories
- measurements
- group Id
- OG003
- spread
- 105.2
- value
- 280.691
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 6 hours post-dose
- categories
- measurements
- group Id
- OG003
- spread
- 102.7
- value
- 202.345
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 6
- units
- Participants
- title
- 8 hours post-dose
- categories
- measurements
- group Id
- OG003
- spread
- 84.1
- value
- 174.079
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- 10 hours post-dose
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 29
- group Id
- OG002
- value
- 18
- group Id
- OG003
- value
- 6
- units
- Participants
- description
- Blood samples were collected at specified timepoints to obtain plasma concentrations of surufatinib at steady state on Cycle 1 Day 15.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- 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.
- id
- OG000
- title
- Cohort A (NET, Lung)
- description
- 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.
- id
- OG001
- title
- Cohort B (NET, Small Bowel)
- description
- 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.
- id
- OG002
- title
- Cohort C (NET, Other)
- description
- 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.
- id
- OG003
- title
- Cohort D (NET, Any)
- param Type
- GEOMETRIC_MEAN
- population Description
- 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.
- reporting Status
- POSTED
- time Frame
- 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
- title
- Plasma Concentrations of Surufatinib
- type
- SECONDARY
- unit Of Measure
- nanogram/milliliter
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