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NCT01957644 · OUTCOME

Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1

Phase I Dose Escalation Trial of Volasertib in Combination With Azacitidine in Patients With MDS or CMML · Source last updated 2019-02-08

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

Measure
NUMBER
Unit
Milligram (mg)
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD.

Analysis population: MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT

Groups in this outcome

Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1

Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)

Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1

Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)

Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2

Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)

Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2

Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-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
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 16
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 15
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 21
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 21

Reported measurements

Source class 1
Values in Milligram (mg) · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1NANot reportedNot reportedNot reportedFinal conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1NANot reportedNot reportedNot reportedFinal conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2NANot reportedNot reportedNot reportedFinal conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2NANot reportedNot reportedNot reportedFinal conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
        group Id
        OG000
        value
        NA
      2. comment
        Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
        group Id
        OG001
        value
        NA
      3. comment
        Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
        group Id
        OG002
        value
        NA
      4. comment
        Final conclusion of the MTD of volasertib in combination with azacitidine could not be drawn in this trial.
        group Id
        OG003
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      1
    4. group Id
      OG003
      value
      1
    units
    Participants
description
The primary objective of the dose-escalation part of this study was to determine the MTD of volasertib in combination with azacitidine. The MTD was to be identified based on the DLT information collected during the first treatment cycle of each dosing schedule. DLT was defined as a non-haematological drug-related toxicity of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3. The MTD corresponded to the highest dose of volasertib and azacitidine at which the incidence of DLT was ≤17% (i.e. 1/6 patients) during Cycle 1. The planned dose escalation schedules of Part 2 were not completed because the trial was prematurely discontinued. Hence, a final conclusion of the MTD of volasertib in combination with azacitidine cannot be drawn in this trial. Number of patients with DLT in cycle 1 in escalation part is presented to determine MTD.
groups
  1. description
    Patients were intravenously administered escalating dose of volasertib 250 milligram (mg) (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 milligram / square meter (mg/m2) once daily on Days 1 to 7 (28- day cycle)
    id
    OG000
    title
    Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 1
  2. description
    Patients were intravenously administered escalating dose of volasertib 300 mg (Volasertib (BI 6727), solution for infusion) on Day 1+15 (28-day cycle) combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    OG001
    title
    Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 1
  3. description
    Patients were intravenously administered escalating dose of volasertib 170 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    OG002
    title
    Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
  4. description
    Patients were intravenously administered escalating dose of volasertib 110 mg/m2 (Volasertib (BI 6727), solution for infusion) on Day1 and Day 7 combined with subcutaneous administration of Azacitidine (powder for reconstitution of an injection suspension) 75 mg/m2 once daily on Days 1 to 7 (28-day cycle)
    id
    OG003
    title
    Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 2
param Type
NUMBER
population Description
MTD set: The MTD set was used for the first treatment cycle (Cycle 1) analysis and excluded any treated patients that missed any dose of trial medication in Cycle 1 for reasons other than DLT
reporting Status
POSTED
time Frame
4 weeks
title
Determination of the Maximum Tolerated Dose (MTD) Based on the Occurrence of Dose-limiting Toxicity (DLT) in Cycle 1
type
PRIMARY
unit Of Measure
Milligram (mg)

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

Preserved source evidence · Not medical advice