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NCT01445080 · OUTCOME

Area Under the Plasma Concentration Versus Time Curve (AUC) 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
8 hours post dose on day 1 of cycle 1

What was measured

Area under the plasma concentration versus time curve (AUC) 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 AML and FLT3-ITD mutation.

Analysis population: Data was and never will be collected

Groups in this outcome

STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)

Patients receive sorafenib as in stratum 1 at the MTD determined in stratum 2. Patients undergo blood sample collection for pharmacokinetics, pharmacodynamics (in leukemia blasts only), circulating endothelial cells (CEC), circulating CEC precursors (CECP), VEGF and VEGF-2 , gene expression, proteomic profile, ERK phosphorylation, and FLT3 phosphorylation activity. Tumor tissue samples may also be analyzed for the presence of ras, raf, or FLT3.

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

Analysis denominator · Participants

GroupSource count
STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Area under the plasma concentration versus time curve (AUC) 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 AML and FLT3-ITD mutation.
groups
  1. description
    Patients receive sorafenib as in stratum 1 at the MTD determined in stratum 2. Patients undergo blood sample collection for pharmacokinetics, pharmacodynamics (in leukemia blasts only), circulating endothelial cells (CEC), circulating CEC precursors (CECP), VEGF and VEGF-2 , gene expression, proteomic profile, ERK phosphorylation, and FLT3 phosphorylation activity. Tumor tissue samples may also be analyzed for the presence of ras, raf, or FLT3.
    id
    OG000
    title
    STRATUM III (ACUTE MYELOID LEUKEMIA AND FLT3-ITD MUTATION)
population Description
Data was and never will be collected
reporting Status
POSTED
time Frame
8 hours post dose on day 1 of cycle 1
title
Area Under the Plasma Concentration Versus Time Curve (AUC) of Sorafenib
type
PRIMARY

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

Preserved source evidence · Not medical advice