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NCT01136733 · OUTCOME

Time to Cmax (Tmax) for Lenvatinib When Administered Alone or in Combination With Everolimus

A Study of E7080 Alone, and in Combination With Everolimus in Subjects With Unresectable Advanced or Metastatic Renal Cell Carcinoma Following One Prior Vascular Endothelial Growth Factor (VEGF)-Targeted Treatment · Source last updated 2019-02-27

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

Measure
MEDIAN
Unit
Hours
Interval / dispersion
Full Range
Time frame
Phase 2: Cycle 1 Day 15

What was measured

Tmax for lenvatinib was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach maximum concentration (Cmax) of lenvatinib in plasma.

Analysis population: PK sub analysis set

Groups in this outcome

Phase 2: 18 mg Lenvatinib + 5 mg Everolimus

Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.

Phase 2: 24 mg Lenvatinib

Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.

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

Analysis denominator · Participants

GroupSource count
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus8
Phase 2: 24 mg Lenvatinib9

Reported measurements

Source class 1
Values in Hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus2.0Not reported2.08.2Not reported
Phase 2: 24 mg Lenvatinib4.0Not reported0.58.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.0
        upper Limit
        8.2
        value
        2.0
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        8.0
        value
        4.0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      9
    units
    Participants
description
Tmax for lenvatinib was the amount of time taken after administration of study treatment on Cycle 1 Day 15 to reach maximum concentration (Cmax) of lenvatinib in plasma.
dispersion Type
Full Range
groups
  1. description
    Oral lenvatinib (18mg) and everolimus (5 mg) were taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles. Treatment cycles began with the first dose of study drug in Cycle 1 and continued in 28-day (4-week) consecutive cycles until completion of the off-treatment assessments (within 30 days after the last study treatment administration). Study drugs were administered at the clinic for the first dose and on the pharmacokinetic (PK) sampling days.
    id
    OG000
    title
    Phase 2: 18 mg Lenvatinib + 5 mg Everolimus
  2. description
    Oral lenvatinib (24 mg) was taken once daily in the morning (consistently with or without food) with water, in continuous 28-day (4-week) cycles.
    id
    OG001
    title
    Phase 2: 24 mg Lenvatinib
param Type
MEDIAN
population Description
PK sub analysis set
reporting Status
POSTED
time Frame
Phase 2: Cycle 1 Day 15
title
Time to Cmax (Tmax) for Lenvatinib When Administered Alone or in Combination With Everolimus
type
SECONDARY
unit Of Measure
Hours

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

Preserved source evidence · Not medical advice