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NCT04238819 · OUTCOME

MTD of Abemaciclib in Part B

A Study of Abemaciclib (LY2835219) in Combination With Other Anti-Cancer Treatments in Children and Young Adult Participants With Solid Tumors, Including Neuroblastoma · Source last updated 2026-03-02

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

Measure
NUMBER
Unit
mg/m² BID
Interval / dispersion
Not reported
Time frame
Cycle 1 (21 Days)

What was measured

The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.

Analysis population: All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.

Groups in this outcome

Part B - Abemaciclib

Participants received: * Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.

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 B - Abemaciclib26

Reported measurements

Source class 1
Values in mg/m² BID · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part B - AbemaciclibNANot reportedNot reportedNot reportedInsufficient number of participants experienced DLT. Thus, MTD could not be calculated.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Insufficient number of participants experienced DLT. Thus, MTD could not be calculated.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      26
    units
    Participants
description
The MTD was defined as the highest dose level at which less than 33% of participants experienced a DLT.
groups
  1. description
    Participants received: * Abemaciclib: 70 mg/m² or 90 mg/m² or 115 mg/m², administered orally BID. * Temozolomide: 100 mg/m²/day or 150 mg/m²/day, administered orally on Days 1-5 of each cycle. Treatment continued until progressive disease, a discontinuation criterion, or unacceptable toxicity. Each cycle lasted 21 days.
    id
    OG000
    title
    Part B - Abemaciclib
param Type
NUMBER
population Description
All participants in Part B who received at least one dose of abemaciclib and had evaluable data for this outcome.
reporting Status
POSTED
time Frame
Cycle 1 (21 Days)
title
MTD of Abemaciclib in Part B
type
PRIMARY
unit Of Measure
mg/m² BID

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

Preserved source evidence · Not medical advice