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NCT04238819 · OUTCOME

Percentage of Participants With ORR: 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
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Date of first dose to disease progression or death (Up to 25 Months)

What was measured

ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO). RECIST was used for solid tumors and RANO was used for brain tumors. * CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO). * PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and \>50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).

Analysis population: All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.

Groups in this outcome

Part B Cohort B1

Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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.

Part B Cohort B2

Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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.

Part B Cohort B3

Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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.

Part B Cohort B5

Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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 Cohort B13
Part B Cohort B29
Part B Cohort B33
Part B Cohort B511

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part B Cohort B10Not reportedNANANone of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
Part B Cohort B20Not reportedNANANone of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
Part B Cohort B333.3Not reported0.086.7Not reported
Part B Cohort B518.2Not reported0.041.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        None of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. comment
        None of the participants achieved ORR. Thus, upper and lower limits of confidence intervals could not be calculated.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        86.7
        value
        33.3
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        41.0
        value
        18.2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      11
    units
    Participants
description
ORR: Percentage of participants with best response of CR or PR per Response Evaluation Criteria in Solid Tumors (RECIST) or Response Assessment in Neuro-Oncology (RANO). RECIST was used for solid tumors and RANO was used for brain tumors. * CR is defined as the disappearance of all target lesions (RECIST) and disappearance of all enhancing measurable and non-measurable disease, no new lesions; stable or improved non-enhancing lesions; and patient must be off corticosteroids and stable or improved clinically (RANO). * PR is defined as a 30% decrease in the sum of diameters of target lesions (RECIST) and \>50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions, no progression of non-measurable disease, no new lesions, stable/improved non-enhancing lesions on same or lower dose of corticosteroids and patient is stable or improved clinically (RANO).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received: * Abemaciclib: 70 mg/m², administered orally BID. * Temozolomide: 100 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 Cohort B1
  2. description
    Participants received: * Abemaciclib: 90 mg/m², administered orally BID. * Temozolomide: 100 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
    OG001
    title
    Part B Cohort B2
  3. description
    Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 100 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
    OG002
    title
    Part B Cohort B3
  4. description
    Participants received: * Abemaciclib: 115 mg/m², administered orally BID. * Temozolomide: 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
    OG003
    title
    Part B Cohort B5
param Type
NUMBER
population Description
All participants in Part B who received at least one dose of the study drug and had evaluable data for this outcome. Per pre-specified statistical analysis plan, analysis was performed as per the study treatments received.
reporting Status
POSTED
time Frame
Date of first dose to disease progression or death (Up to 25 Months)
title
Percentage of Participants With ORR: Part B
type
SECONDARY
unit Of Measure
Percentage of participants

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

Preserved source evidence · Not medical advice