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NCT04447755 · OUTCOME

Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)

A Study of Lenvatinib (MK-7902) in Pediatric Participants With Relapsed or Refractory Solid Malignancies (MK-7902-013/E7080) · Source last updated 2025-10-03

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

Measure
GEOMETRIC_MEAN
Unit
ng*hr/ml
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.

What was measured

Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.

Analysis population: All participants who received at least one dose of study treatment and had at least one measurable postdose plasma concentration with an adequately documented dosing history were analyzed. Lenvatinib exposures are reported by the four protocol pre-specified cohorts at the time of enrollment (EWS, RMS, HGG, and Other Solid Tumors excluding Osteosarcoma). For the purposes of the analysis, AUCss was reported for participants with "Other Solid Tumors" irrespective of tumor type.

Groups in this outcome

Ewing Sarcoma

Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.

Rhabdomyosarcoma

Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

High Grade Glioma

Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

Other Solid Tumors Excluding Osteosarcoma

Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.

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

Analysis denominator · Participants

GroupSource count
Ewing Sarcoma9
Rhabdomyosarcoma17
High Grade Glioma8
Other Solid Tumors Excluding Osteosarcoma91

Reported measurements

Source class 1
Values in ng*hr/ml · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Ewing Sarcoma589631.2Not reportedNot reportedNot reported
Rhabdomyosarcoma391532.9Not reportedNot reportedNot reported
High Grade Glioma366043.5Not reportedNot reportedNot reported
Other Solid Tumors Excluding Osteosarcoma499053.2Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        31.2
        value
        5896
      2. group Id
        OG001
        spread
        32.9
        value
        3915
      3. group Id
        OG002
        spread
        43.5
        value
        3660
      4. group Id
        OG003
        spread
        53.2
        value
        4990
denoms
  1. counts
    1. group Id
      OG000
      value
      9
    2. group Id
      OG001
      value
      17
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      91
    units
    Participants
description
Blood samples were taken predose and at specified times postdose on Days 1-28 to determine the AUCss of Lenvatinib.
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Participants with Ewing sarcoma received lenvatinib 14 mg/m\^2 once daily (QD) orally until progressive disease or unacceptable toxicity.
    id
    OG000
    title
    Ewing Sarcoma
  2. description
    Participants with rhabdomyosarcoma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG001
    title
    Rhabdomyosarcoma
  3. description
    Participants with high grade glioma received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG002
    title
    High Grade Glioma
  4. description
    Participants with other solid tumors received lenvatinib 14 mg/m\^2 QD orally until progressive disease or unacceptable toxicity.
    id
    OG003
    title
    Other Solid Tumors Excluding Osteosarcoma
param Type
GEOMETRIC_MEAN
population Description
All participants who received at least one dose of study treatment and had at least one measurable postdose plasma concentration with an adequately documented dosing history were analyzed. Lenvatinib exposures are reported by the four protocol pre-specified cohorts at the time of enrollment (EWS, RMS, HGG, and Other Solid Tumors excluding Osteosarcoma). For the purposes of the analysis, AUCss was reported for participants with "Other Solid Tumors" irrespective of tumor type.
reporting Status
POSTED
time Frame
Cycle 1 Day 1 (0.5-4 and 6-10 hours post-dose), Cycle 1 Day 15 (pre-dose, 0.5-4, and 6-10 hours post-dose), and Cycle 2 Day 1 (pre-dose and 2-12 hours post-dose). A cycle is 28 days.
title
Area Under the Concentration-Time Curve of Lenvatinib at Steady State (AUCss)
type
SECONDARY
unit Of Measure
ng*hr/ml

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Preserved source evidence · Not medical advice