Participant flow

This is a Phase 1 Study of Eribulin Mesylate in Pediatric Participants With Recurrent or Refractory Solid Tumors (Excluding [Central Nervous System] CNS), Including Lymphomas · Source last updated 2019-01-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received eribulin mesylate (E7389) 1.1 milligram per square meter (mg/m\^2), intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 4 cycles, or until progressive disease (PD) or unacceptable toxicity or drug related dose-limiting toxicities (DLT's).

   id

   FG000

   title

   Part A1: Eribulin Mesylate 1.1 mg/m^2

2. description

   Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 8 cycles, or until PD or unacceptable toxicity or drug related DLT's.

   id

   FG001

   title

   Part A1: Eribulin Mesylate 1.4 mg/m^2

3. description

   Participants received eribulin mesylate 1.8 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 5 cycles, or until PD or unacceptable toxicity or drug related DLT's.

   id

   FG002

   title

   Part A1: Eribulin Mesylate 1.8 mg/m^2

4. description

   Participants received eribulin mesylate 1.4 mg/m\^2, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to 2 cycles, or until PD or unacceptable toxicity or drug related DLT's for evaluation of pharmacokinetics (PK).

   id

   FG003

   title

   Part A1: Eribulin Mesylate PK Expansion

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      type

      Physician Decision

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      type

      Evidence of progressive disease

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         5

      4. group Id

         FG003

         num Subjects

         5

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

In Part A1, a total of 23 participants of greater than or equal to (\>=) 12 months were enrolled, of which 22 were treated in the study. In Part A2, the study was open for the enrolment of infant participants of less than 12 months of age, however no participants were enrolled into this part.

recruitment Details

Participants took part in the study at 18 investigative sites in the United States from 31 July 2014 to 28 January 2016.

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Preserved source evidence · Not medical advice