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NCT03387020 · OUTCOME

Average Tumor and Plasma Concentrations of Ribociclib for the Surgical Study

Ribociclib and Everolimus in Treating Children With Recurrent or Refractory Malignant Brain Tumors · Source last updated 2021-08-27

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

Measure
MEDIAN
Unit
ratio
Interval / dispersion
Full Range
Time frame
Surgical study: Prior to starting ribociclib (day -7 or -10), prior to ribociclib dose on days -5 & -2, day 0, and at the time of surgery

What was measured

Average tumor Ribociclib concentrations will be compared to plasma concentrations. The mean tumor-to-plasma ratio of Ribociclib at the time of surgery will be described.

Analysis population: Patients who were enrolled on surgical study and with tumor and matching plasma samples available.

Groups in this outcome

Surgical

Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery

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

Analysis denominator · Participants

GroupSource count
Surgical5

Reported measurements

Source class 1
Values in ratio · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Surgical14.6Not reported2.2253.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.22
        upper Limit
        53.4
        value
        14.6
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
Average tumor Ribociclib concentrations will be compared to plasma concentrations. The mean tumor-to-plasma ratio of Ribociclib at the time of surgery will be described.
dispersion Type
Full Range
groups
  1. description
    Patients who are undergoing surgery also receive ribociclib PO QD on days 7-10 at 120 mg/m2/day before surgery
    id
    OG000
    title
    Surgical
param Type
MEDIAN
population Description
Patients who were enrolled on surgical study and with tumor and matching plasma samples available.
reporting Status
POSTED
time Frame
Surgical study: Prior to starting ribociclib (day -7 or -10), prior to ribociclib dose on days -5 & -2, day 0, and at the time of surgery
title
Average Tumor and Plasma Concentrations of Ribociclib for the Surgical Study
type
PRIMARY
unit Of Measure
ratio

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice