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NCT02201329 · OUTCOME

Maximum Tolerated Dose of Volasertib

Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia · Source last updated 2018-07-30

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

Measure
NUMBER
Unit
mg
Interval / dispersion
Not reported
Time frame
Up to 57 days.

What was measured

This outcome measure presents MTD of Volasertib in Combination with Azacitidine. The MTD was defined as the highest dose level at which Dose Limiting Toxicities (DLTs) were reported in not more than 1 in 6 evaluable patients during Cycle 1.

Analysis population: MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.

Groups in this outcome

Volasertib 200 mg

The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment 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
Volasertib 200 mg5

Reported measurements

Source class 1
Values in mg · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 200 mgNANot reportedNot reportedNot reportedOn the basis of DLTs, the MTD of Volasertib administered intravenously on Days 1 and 15 in 28-day cycles in combination with Azacitidine was considered to be less than 200 mg.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        On the basis of DLTs, the MTD of Volasertib administered intravenously on Days 1 and 15 in 28-day cycles in combination with Azacitidine was considered to be less than 200 mg.
        group Id
        OG000
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    units
    Participants
description
This outcome measure presents MTD of Volasertib in Combination with Azacitidine. The MTD was defined as the highest dose level at which Dose Limiting Toxicities (DLTs) were reported in not more than 1 in 6 evaluable patients during Cycle 1.
groups
  1. description
    The patients received Volasertib 200 mg administered by Intravenous Infusion (IV) over 60 minutes on Day 1 and Day 15 of 28-day and Azacitidine 75 mg/m\^2 administered by subcutaneous injection on days 1-7 of 28 day treatment cycle.
    id
    OG000
    title
    Volasertib 200 mg
param Type
NUMBER
population Description
MTD Set: This patient set included all patients in the treated set who were evaluable for MTD determination.
reporting Status
POSTED
time Frame
Up to 57 days.
title
Maximum Tolerated Dose of Volasertib
type
PRIMARY
unit Of Measure
mg

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

Preserved source evidence · Not medical advice