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NCT00560391 · OUTCOME

Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone

Dasatinib in Combination With Revlimid (and Dexamethasone) · Source last updated 2016-08-04

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
From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).

What was measured

The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.

Analysis population: All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)

Groups in this outcome

Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).

Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg

Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.

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

Analysis denominator · Participants

GroupSource count
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg6
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg3
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg3
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg6
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg4

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg0Not reportedNot reportedNot reportedNot reported
Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg0Not reportedNot reportedNot reportedNot reported
Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg0Not reportedNot reportedNot reportedNot reported
Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg0Not reportedNot reportedNot reportedNot reported
Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      4
    units
    Participants
description
The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study.
groups
  1. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    OG000
    title
    Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg
  2. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    OG001
    title
    Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  3. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    OG002
    title
    Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg
  4. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
    id
    OG003
    title
    Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
  5. description
    Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
    id
    OG004
    title
    Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg
param Type
NUMBER
population Description
All treated participants, participants who received at least 1 dose of dasatinib. (Participants included from Cohort 5 are those involved in the dose escalation phase only.)
reporting Status
POSTED
time Frame
From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
title
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice