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NCT01321554 · OUTCOME

Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Trial of Lenvatinib (E7080) in 131I-Refractory Differentiated Thyroid Cancer (DTC) · Source last updated 2023-06-22

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

Measure
MEDIAN
Unit
nanogram*hour per milliliter (ng*h/mL)
Interval / dispersion
Full Range
Time frame
Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose

Analysis population: The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.

Groups in this outcome

Randomization Phase: Lenvatinib 24 mg

Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.

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

Analysis denominator · Participants

GroupSource count
Randomization Phase: Lenvatinib 24 mg260

Reported measurements

Source class 1
Values in nanogram*hour per milliliter (ng*h/mL) · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Randomization Phase: Lenvatinib 24 mg3490Not reported141010700Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1410
        upper Limit
        10700
        value
        3490
denoms
  1. counts
    1. group Id
      OG000
      value
      260
    units
    Participants
dispersion Type
Full Range
groups
  1. description
    Participants received lenvatinib 24 mg, hard capsule, orally, once daily, until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
    id
    OG000
    title
    Randomization Phase: Lenvatinib 24 mg
param Type
MEDIAN
population Description
The PK analysis set included all the participants who received at least one dose of study drug and had evaluable PK data.
reporting Status
POSTED
time Frame
Cycle 1 Days 1 and 15: 0-10 hours postdose; Cycle 2 Day 1: 0-12 hour postdose
title
Pharmacokinetic (PK) Profile of Lenvatinib: Area Under the Plasma Concentration Curve
type
SECONDARY
unit Of Measure
nanogram*hour per milliliter (ng*h/mL)

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

Preserved source evidence · Not medical advice