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NCT02171260 · OUTCOME

Maximum Tolerated Dose (MTD) of Eribulin Mesylate

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.

Measure
NUMBER
Unit
mg/m^2
Interval / dispersion
Not reported
Time frame
First dose of study drug (Baseline) up to Cycle 1 Day 21

What was measured

MTD: maximum dose at which \<one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of \<3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade \<=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing \>=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets\<75,000/mm\^3 on Day 8 that does not resolve to absolute neutrophil count \>=750/mm\^3 and platelets\>=75,000/mm\^3 by Day 11, neutropenia for \>7 days; platelet count \<25,000/mm\^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing \>14 days delay between treatment cycles.

Analysis population: The dose evaluable set (DES) included all participants who were judged as DLT evaluable as recorded in the database. In order to be DLT evaluable, all participants had to complete Cycle 1.

Groups in this outcome

Part A1: All Participants

All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Part A1: All Participants20

Reported measurements

Source class 1
Values in mg/m^2 · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A1: All Participants1.4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1.4
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
MTD: maximum dose at which \<one third participants had DLT in Cycle 1. DLT: Grade 3/4 drug-related non hematological toxicity (except Grade 3 nausea, vomiting of \<3 days, Grade 3 liver enzyme elevation with alanine transaminase/aspartate transaminase and gamma glutamyl transferase that returned to Grade \<=1 or baseline prior to next dose; Grade 3 fever, infection, hypophosphatemia, hypokalemia, hypocalcemia/hypomagnesemia responsive to oral supplementation). Non-hematological toxicity causing \>=14 days delay between treatment cycles. Haematological DLTs included: Grade 4 neutropenia/platelets\<75,000/mm\^3 on Day 8 that does not resolve to absolute neutrophil count \>=750/mm\^3 and platelets\>=75,000/mm\^3 by Day 11, neutropenia for \>7 days; platelet count \<25,000/mm\^3, or required platelet transfusion, on 2 separate days within 7-day period;Grade 3 thrombocytopenia complicated by bleeding and/or required platelet transfusion;myelosuppression causing \>14 days delay between treatment cycles.
groups
  1. description
    All participants received eribulin mesylate 1.1 mg/m\^2 or 1.4 mg/m\^2 or 1.8 mg/m\^2 or 1.4 mg/m\^2 in PK expansion, intravenously over 2 to 5 minutes on Days 1 and 8 of each 21-day treatment cycle for up to a maximum of 8 cycles or until PD or unacceptable toxicity or drug related DLT's.
    id
    OG000
    title
    Part A1: All Participants
param Type
NUMBER
population Description
The dose evaluable set (DES) included all participants who were judged as DLT evaluable as recorded in the database. In order to be DLT evaluable, all participants had to complete Cycle 1.
reporting Status
POSTED
time Frame
First dose of study drug (Baseline) up to Cycle 1 Day 21
title
Maximum Tolerated Dose (MTD) of Eribulin Mesylate
type
PRIMARY
unit Of Measure
mg/m^2

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice