Participant flow

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.

groups

1. description

   Patients with NET of lung origin received surufatinib 300 milligrams (mg) orally once daily (QD) in treatment cycles of 28 days starting on Cycle (C)1 Day (D)1 until disease progression, death, unacceptable toxicity, withdrawal of consent or lost to follow-up.

   id

   FG000

   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

   FG001

   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

   FG002

   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

   FG003

   title

   Cohort D (NET, Any)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         0

      type

      New Antitumor Therapy

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         4

      type

      Withdrawal of Consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Adverse Event

   5. reasons

      1. group Id

         FG000

         num Subjects

         9

      2. group Id

         FG001

         num Subjects

         13

      3. group Id

         FG002

         num Subjects

         7

      4. group Id

         FG003

         num Subjects

         0

      type

      Disease Progression

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Physician Decision

   7. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Study Terminated by Sponsor

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         32

      3. group Id

         FG002

         num Subjects

         20

      4. group Id

         FG003

         num Subjects

         6

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         31

      3. group Id

         FG002

         num Subjects

         20

      4. group Id

         FG003

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

The study enrolled patients in 4 cohorts of varying NETs as follows: * Cohort A - NET of lung origin (NET, lung) * Cohort B - NET of small bowel origin (NET, small bowel) * Cohort C - NET of non-small bowel, non-pancreas, and non-lung origin (NET, other) * Cohort D - NET of any origin/drug-drug interaction sub-study (NET, any) The study was terminated early based on the strategic re-evaluation of the clinical development program for surufatinib and not due to any safety concerns.

recruitment Details

This Phase 2, multicenter, open-label study was conducted in patients with locally advanced or metastatic low to intermediate grade (Grade 1 or Grade 2), well-differentiated neuroendocrine tumors (NETs).

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Preserved source evidence · Not medical advice