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NCT02255461 · OUTCOME

Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II

Palbociclib Isethionate in Treating Younger Patients With Recurrent, Progressive, or Refractory Central Nervous System Tumors · Source last updated 2021-03-02

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

Measure
NUMBER
Unit
mg/m2/day
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.

Analysis population: Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.

Groups in this outcome

Stratum II

Of 14 patients enrolled on stratum II, 3 patients were not evaluable for dose finding assessment: 2 patients due to receiving less than required dose of study drug and 1 due to withdrawal consent prior to beginning protocol therapy. The remaining 11 patients were used to determine the MTD for stratum II.

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

Analysis denominator · Participants

GroupSource count
Stratum II11

Reported measurements

Source class 1
Values in mg/m2/day · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum II75Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        75
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    units
    Participants
description
Rolling-6 design was used to estimate MTD. The MTD was empirically defined as the highest dose level at which six patients were treated with at most one patient experiencing a DLT and the next higher dose level had been determined to be too toxic. Stratum II consisted of heavily pre-treated patients.
groups
  1. description
    Of 14 patients enrolled on stratum II, 3 patients were not evaluable for dose finding assessment: 2 patients due to receiving less than required dose of study drug and 1 due to withdrawal consent prior to beginning protocol therapy. The remaining 11 patients were used to determine the MTD for stratum II.
    id
    OG000
    title
    Stratum II
param Type
NUMBER
population Description
Patients who were enrolled on stratum II and were evaluable for dose finding assessment were used to determine the MTD for stratum II.
reporting Status
POSTED
time Frame
4 weeks
title
Maximum Tolerated Dose (MTD) of Palbociclib in Stratum II
type
PRIMARY
unit Of Measure
mg/m2/day

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

Preserved source evidence · Not medical advice