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NCT04238819 · OUTCOME

Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)

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
milligrams/squared meters (mg/m²) BID
Interval / dispersion
Not reported
Time frame
Cycles 1 and 2 (21 Day Cycles)

What was measured

The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 50 mg/m²/day irinotecan and 100 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.

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

Groups in this outcome

Part A - Abemaciclib

* Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle. * Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.

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 - Abemaciclib20

Reported measurements

Source class 1
Values in milligrams/squared meters (mg/m²) BID · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A - Abemaciclib55Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        55
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
The RP2D of abemaciclib was determined based on the totality of safety, tolerability, and pharmacokinetic results. RP2D of abemaciclib in combination with 50 mg/m²/day irinotecan and 100 mg/m²/day temozolomide on days 1-5 of 21-day cycles was reported.
groups
  1. description
    * Cohort A1: 70 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle. * Cohort A-1: 55 mg/m² abemaciclib administered orally BID in combination with 50 mg/m²/day irinotecan administered IV on Days 1-5 of each 21-day cycle and 100 mg/m²/day temozolomide administered orally on Days 1-5 of each 21-day cycle.
    id
    OG000
    title
    Part A - Abemaciclib
param Type
NUMBER
population Description
All participants in Part A who received at least one dose of abemaciclib and had evaluable data for this outcome.
reporting Status
POSTED
time Frame
Cycles 1 and 2 (21 Day Cycles)
title
Recommended Phase 2 Dose (RP2D) of Abemaciclib in Combination With Irinotecan and Temozolomide (Part A)
type
PRIMARY
unit Of Measure
milligrams/squared meters (mg/m²) BID

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

Preserved source evidence · Not medical advice