Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00261846 · OUTCOME

Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias · Source last updated 2017-07-27

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

Measure
MEDIAN
Unit
hrs
Interval / dispersion
Full Range
Time frame
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15

What was measured

Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.

Analysis population: Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.

Groups in this outcome

Bosutinib 400 mg (Part 1)

Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.

Bosutinib 500 mg (Part 1)

Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.

Bosutinib 600 mg (Part 1)

Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.

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

Analysis denominator · Participants

GroupSource count
Bosutinib 400 mg (Part 1)3
Bosutinib 500 mg (Part 1)3
Bosutinib 600 mg (Part 1)12

Reported measurements

Source class 1
Values in hrs · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Bosutinib 400 mg (Part 1)4.05Not reported3.086.08Not reported
Bosutinib 500 mg (Part 1)6.05Not reported4.008.00Not reported
Bosutinib 600 mg (Part 1)6.00Not reported2.8311.08Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.08
        upper Limit
        6.08
        value
        4.05
      2. group Id
        OG001
        lower Limit
        4.00
        upper Limit
        8.00
        value
        6.05
      3. group Id
        OG002
        lower Limit
        2.83
        upper Limit
        11.08
        value
        6.00
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      12
    units
    Participants
description
Time to reach maximum observed plasma concentration over 24 hours at steady state (ss), on Day 15.
dispersion Type
Full Range
groups
  1. description
    Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    id
    OG000
    title
    Bosutinib 400 mg (Part 1)
  2. description
    Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study.
    id
    OG001
    title
    Bosutinib 500 mg (Part 1)
  3. description
    Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in AP-CML Part 2 of the study.
    id
    OG002
    title
    Bosutinib 600 mg (Part 1)
param Type
MEDIAN
population Description
Evaluable population included all enrolled participants who received at least 1 dose of study medication and had an adequate baseline efficacy assessment.
reporting Status
POSTED
time Frame
0 (pre-dose), 1, 2, 3, 4, 6, 8, 24 hours post-dose on Day 15
title
Time to Reach Maximum Observed Plasma Concentration at Steady State (Tmax,ss) - Part 1
type
PRIMARY
unit Of Measure
hrs

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

Preserved source evidence · Not medical advice