Skip to content
Triangle logo TriangleGet started
← Full study record

NCT04238819 · OUTCOME

Duration of Response (DoR): Parts A and 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
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Date of first evidence of a CR or PR to date of objective disease progression or death due to any cause (Up to 25 Months)

What was measured

DoR is the time between first evidence of CR or PR and disease progression or death due to any cause. 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 Parts A and 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 A Cohort A1

Participants received: * Abemaciclib: 70 mg/m², administered orally twice daily (BID). * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * 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 A Cohort A-1

Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * 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 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 A Cohort A10
Part A Cohort A-11
Part B Cohort B10
Part B Cohort B20
Part B Cohort B31
Part B Cohort B52

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Part A Cohort A-122.59Not reportedNANAOnly 1 participant had events, hence confidence interval limits could not be calculated.
Part B Cohort B37.82Not reportedNANAOnly 1 participant had events, hence confidence interval limits could not be calculated.
Part B Cohort B50.03Not reportedNANAUpper and lower limit confidence intervals cannot be calculated as both participants had the same Duration of Response of 0.03 months.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Only 1 participant had events, hence confidence interval limits could not be calculated.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        22.59
      2. comment
        Only 1 participant had events, hence confidence interval limits could not be calculated.
        group Id
        OG004
        lower Limit
        NA
        upper Limit
        NA
        value
        7.82
      3. comment
        Upper and lower limit confidence intervals cannot be calculated as both participants had the same Duration of Response of 0.03 months.
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        0.03
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    5. group Id
      OG004
      value
      1
    6. group Id
      OG005
      value
      2
    units
    Participants
description
DoR is the time between first evidence of CR or PR and disease progression or death due to any cause. 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 twice daily (BID). * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * 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 A Cohort A1
  2. description
    Participants received: * Abemaciclib: 55 mg/m², administered orally BID. * Irinotecan: 50 mg/m²/day, administered IV on Days 1-5 of each cycle. * 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 A Cohort A-1
  3. 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
    OG002
    title
    Part B Cohort B1
  4. 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
    OG003
    title
    Part B Cohort B2
  5. 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
    OG004
    title
    Part B Cohort B3
  6. 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
    OG005
    title
    Part B Cohort B5
param Type
MEDIAN
population Description
All participants in Parts A and 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 evidence of a CR or PR to date of objective disease progression or death due to any cause (Up to 25 Months)
title
Duration of Response (DoR): Parts A and B.
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice