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NCT01445080 · OUTCOME

Maximum Serum Concentration (Cmax) of Sorafenib

Sorafenib in Treating Young Patients With Relapsed or Refractory Solid Tumors or Leukemia · Source last updated 2021-02-02

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

Measure
MEAN
Unit
µg/ml
Interval / dispersion
Standard Error
Time frame
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose

What was measured

Maximum serum concentration (Cmax) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.

Analysis population: Data was not collected for patients from Part A:130 mg/m\^2

Groups in this outcome

Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2

Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.

Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2

Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.

Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.

Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2

Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.

Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2

Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.

Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.

PK Cohort Expanded: BAY 43-9006 200 mg/m^2

Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.

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

Analysis denominator · Participants

GroupSource count
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^24
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^29
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^24
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^21
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^24
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^21
PK Cohort Expanded: BAY 43-9006 200 mg/m^211

Reported measurements

Source class 1
Values in µg/ml · Interval/dispersion: Standard Error
GroupValueSpreadLowerUpperComment
Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^20.710.53Not reportedNot reportedNot reported
Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^21.881.55Not reportedNot reportedNot reported
Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^21.981.25Not reportedNot reportedNot reported
Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^21.800Not reportedNot reportedNot reported
Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^25.974.45Not reportedNot reportedNot reported
Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^25.020Not reportedNot reportedNot reported
PK Cohort Expanded: BAY 43-9006 200 mg/m^27.95.43Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.53
        value
        0.71
      2. group Id
        OG001
        spread
        1.55
        value
        1.88
      3. group Id
        OG002
        spread
        1.25
        value
        1.98
      4. group Id
        OG003
        spread
        0
        value
        1.80
      5. group Id
        OG004
        spread
        4.45
        value
        5.97
      6. group Id
        OG005
        spread
        0
        value
        5.02
      7. group Id
        OG006
        spread
        .43
        value
        7.95
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      1
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      1
    7. group Id
      OG006
      value
      11
    units
    Participants
description
Maximum serum concentration (Cmax) of sorefenib administered orally as tablets, BID approximately every 12 hours for cycles of 28 days with no rest period between cycles to children with refractory solid tumors or leukemias.
dispersion Type
Standard Error
groups
  1. description
    Patients receive oral sorafenib 105 mg/m\^2 every 12 hours.
    id
    OG000
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 105 mg/m^2
  2. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    OG001
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 150 mg/m^2
  3. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    OG002
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 200 mg/m^2
  4. description
    Patients receive oral sorafenib 250 mg/m\^2 every 12 hours.
    id
    OG003
    title
    Part A: Refractory Solid Tumors: BAY 43-9006 250 mg/m^2
  5. description
    Patients receive oral sorafenib 150 mg/m\^2 every 12 hours.
    id
    OG004
    title
    Part B: Refractory Leukemia: BAY 43-9006 150 mg/m^2
  6. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    OG005
    title
    Part B: Refractory Leukemia: BAY 43-9006 200 mg/m^2
  7. description
    Patients receive oral sorafenib 200 mg/m\^2 every 12 hours.
    id
    OG006
    title
    PK Cohort Expanded: BAY 43-9006 200 mg/m^2
param Type
MEAN
population Description
Data was not collected for patients from Part A:130 mg/m\^2
reporting Status
POSTED
time Frame
During cycle 1 or cycle 2 after at least 14 consecutive days of sorafenib administration Pre-dose, 0.5, 1, 2, 3, 5, 8 hours post dose
title
Maximum Serum Concentration (Cmax) of Sorafenib
type
PRIMARY
unit Of Measure
µg/ml

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

Preserved source evidence · Not medical advice