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NCT04579679 · OUTCOME

Progression-Free Survival (PFS)

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
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

What was measured

The PFS was defined as the time from the start of study drug until the first objective PD as defined by RECIST v1.1 or death, whichever came first. 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.

Analysis population: The safety analysis set included all patients who received at least 1 dose of surufatinib.

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

GroupSource count
Cohort A (NET, Lung)20
Cohort B (NET, Small Bowel)32
Cohort C (NET, Other)20
Cohort D (NET, Any)6

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A (NET, Lung)10.2Not reported5.416.6Not reported
Cohort B (NET, Small Bowel)19.2Not reported8.3NANA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
Cohort C (NET, Other)11.4Not reported5.716.7Not reported
Cohort D (NET, Any)9.8Not reported7.2NANA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.4
        upper Limit
        16.6
        value
        10.2
      2. comment
        NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
        group Id
        OG001
        lower Limit
        8.3
        upper Limit
        NA
        value
        19.2
      3. group Id
        OG002
        lower Limit
        5.7
        upper Limit
        16.7
        value
        11.4
      4. comment
        NA indicates that upper limit of CI was not estimable due to insufficient number of patients with events at study closure.
        group Id
        OG003
        lower Limit
        7.2
        upper Limit
        NA
        value
        9.8
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    2. group Id
      OG001
      value
      32
    3. group Id
      OG002
      value
      20
    4. group Id
      OG003
      value
      6
    units
    Participants
description
The PFS was defined as the time from the start of study drug until the first objective PD as defined by RECIST v1.1 or death, whichever came first. 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.
dispersion Type
95% Confidence Interval
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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
MEDIAN
population Description
The safety analysis set included all patients who received at least 1 dose of surufatinib.
reporting Status
POSTED
time Frame
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
title
Progression-Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice