Skip to content
← Full study record

NCT01371981 · OUTCOME

Sorafenib Steady State Concentration

Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia · Source last updated 2026-06-02

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

Measure
MEDIAN
Unit
Nanogram/Milliliter
Interval / dispersion
Full Range
Time frame
Up to 30 days

What was measured

Median and range of sorafenib steady state concentration for Induction I.

Analysis population: Data reported from Arm C were collected and analyzed regardless of the cohort as pre-specified in the study protocol. Only eligible patients on Arm C with evaluable Sorafenib steady state concentration data during Induction I are reported.

Groups in this outcome

Arm C

Arm C (Cohort 1) IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE chemotherapy as Arm A, Intensification II; sorafenib tosylate PO INT II:cytarabine IT; MA chemotherapy as Arm A, Induction II (HR patients); sorafenib tosylate PO. SCT (HR pts w/ matched family \[MFD\] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis. MAINTENANCE:sorafenib tosylate PO Arm C (Cohort 2 and 3) IND I:cytarabine IT; ADE as Arm A, IND I; sorafenib tosylate PO IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE as Arm A, INT II, \& sorafenib tosylate PO INT II:cytarabine IT; MA as Arm A, IND II (HR patients); sorafenib tosylate PO. SCT (HR pts w/ matched family \[MFD\] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis. MAINTENANCE:sorafenib tosylate PO

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

Analysis denominator · Participants

GroupSource count
Arm C23

Reported measurements

Source class 1
Values in Nanogram/Milliliter · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm C1090.0Not reported290.04740.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        290.0
        upper Limit
        4740.0
        value
        1090.0
denoms
  1. counts
    1. group Id
      OG000
      value
      23
    units
    Participants
description
Median and range of sorafenib steady state concentration for Induction I.
dispersion Type
Full Range
groups
  1. description
    Arm C (Cohort 1) IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE chemotherapy as Arm A, Intensification II; sorafenib tosylate PO INT II:cytarabine IT; MA chemotherapy as Arm A, Induction II (HR patients); sorafenib tosylate PO. SCT (HR pts w/ matched family \[MFD\] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis. MAINTENANCE:sorafenib tosylate PO Arm C (Cohort 2 and 3) IND I:cytarabine IT; ADE as Arm A, IND I; sorafenib tosylate PO IND II:cytarabine IT; cytarabine IV; daunorubicin hydrochloride IV; etoposide IV; sorafenib tosylate PO INT I:cytarabine IT; AE as Arm A, INT II, \& sorafenib tosylate PO INT II:cytarabine IT; MA as Arm A, IND II (HR patients); sorafenib tosylate PO. SCT (HR pts w/ matched family \[MFD\] or unrelated donor): fludarabine phosphate IV; busulfan IV; allogeneic SCT; GVHD prophylaxis. MAINTENANCE:sorafenib tosylate PO
    id
    OG000
    title
    Arm C
param Type
MEDIAN
population Description
Data reported from Arm C were collected and analyzed regardless of the cohort as pre-specified in the study protocol. Only eligible patients on Arm C with evaluable Sorafenib steady state concentration data during Induction I are reported.
reporting Status
POSTED
time Frame
Up to 30 days
title
Sorafenib Steady State Concentration
type
SECONDARY
unit Of Measure
Nanogram/Milliliter

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

Preserved source evidence · Not medical advice