NCT03245151 · OUTCOME

Phase 1: Maximum Plasma Concentration of Lenvatinib (Cmax)

Study of Lenvatinib in Combination With Everolimus in Recurrent and Refractory Pediatric Solid Tumors, Including Central Nervous System Tumors · Source last updated 2023-08-30

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

Measure: MEAN
Unit: nanogram per milliliter (ng/mL)
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

What was measured

Cmax of lenvatinib was quantified using validated liquid LC-MS/MS methods.

Analysis population: Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.

Groups in this outcome

Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2

Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.

Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2

Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.

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

Analysis denominator · Participants

Group	Source count
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	5
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	18

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

Group	Source count
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	5
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	18

Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	240.20	130.892	Not reported	Not reported	Not reported
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	404.13	121.473	Not reported	Not reported	Not reported

Cycle 1 Day 15

Analysis denominator · Participants

Group	Source count
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	5
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	17

Values in nanogram per milliliter (ng/mL) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	314.20	149.527	Not reported	Not reported	Not reported
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	447.62	272.790	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
130.892
value
240.20
group Id
OG001
spread
121.473
value
404.13
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
18
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
spread
149.527
value
314.20
group Id
OG001
spread
272.790
value
447.62
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
17
units
Participants
title
Cycle 1 Day 15

denoms

counts
group Id
OG000
value
5
group Id
OG001
value
18
units
Participants

description

Cmax of lenvatinib was quantified using validated liquid LC-MS/MS methods.

dispersion Type

Standard Deviation

groups

description
Participants with recurrent or refractory solid tumors received lenvatinib 8 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
OG000
title
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2
description
Participants with recurrent or refractory solid tumors received lenvatinib 11 mg/m\^2, capsules, orally, once daily in combination with everolimus 3 mg/m\^2, tablets, orally, once daily in cycle 1 (each cycle was 28 days) until the occurrence of PD, clinical benefit, development of unacceptable toxicity leading to withdrawal from the study, study discontinuation or for a maximum of 18 cycles (each cycle was 28 days) whichever occurred first.
id
OG001
title
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2

param Type

MEAN

population Description

Pharmacokinetic analysis set included participants who had at least one measurable postdose plasma concentration with an adequately documented drug administration history. Here, 'number analyzed' signifies participants who were evaluable for given timepoints of this outcome measure. Pharmacokinetic data was planned to be analyzed for Phase 1 only.

reporting Status

POSTED

time Frame

Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

title

Phase 1: Maximum Plasma Concentration of Lenvatinib (Cmax)

type

SECONDARY

unit Of Measure

nanogram per milliliter (ng/mL)

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Preserved source evidence · Not medical advice