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NCT01957644 · OUTCOME

Number of Participants With Dose Limiting Toxicities (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
participants
Interval / dispersion
Not reported
Time frame
4 weeks

What was measured

Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented .

Analysis population: MTD set

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Volasertib 250 mg + Azacitidine (Escalation Cohort)-Part 11Not reportedNot reportedNot reportedNot reported
Volasertib 300 mg + Azacitidine (Escalation Cohort)- Part 11Not reportedNot reportedNot reportedNot reported
Volasertib 170 mg/m2 + Azacitidine (Escalation Cohort)- Part 20Not reportedNot reportedNot reportedNot reported
Volasertib 110 mg/m2 + Azacitidine (Escalation Cohort)- Part 21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        1
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
Number of participants with Dose Limiting Toxicities (DLT) in Cycle 1 (escalation part to determine MTD) is presented .
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
reporting Status
POSTED
time Frame
4 weeks
title
Number of Participants With Dose Limiting Toxicities (DLT) in Cycle 1
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice