NCT03245151 · OUTCOME

Phase 1: Time to Reach Maximum Plasma Concentration (Cmax) of Lenvatinib (Tmax)

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: MEDIAN
Unit: hours
Interval / dispersion: Full Range
Time frame: Cycle 1 Days 1 and 15: 0-8 hours post-dose (Cycle length=28 days)

What was measured

Tmax 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 hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	3.000	Not reported	2.000	4.000	Not reported
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	2.890	Not reported	1.000	7.78	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 hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 1: Lenvatinib 8 mg/m^2 + Everolimus 3 mg/m^2	3.950	Not reported	2.000	8.05	Not reported
Phase 1: Lenvatinib 11 mg/m^2 + Everolimus 3 mg/m^2	2.950	Not reported	0	8.02	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
2.000
upper Limit
4.000
value
3.000
group Id
OG001
lower Limit
1.000
upper Limit
7.78
value
2.890
denoms
counts
group Id
OG000
value
5
group Id
OG001
value
18
units
Participants
title
Cycle 1 Day 1
categories
measurements
group Id
OG000
lower Limit
2.000
upper Limit
8.05
value
3.950
group Id
OG001
lower Limit
0
upper Limit
8.02
value
2.950
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

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

dispersion Type

Full Range

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

MEDIAN

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: Time to Reach Maximum Plasma Concentration (Cmax) of Lenvatinib (Tmax)

type

SECONDARY

unit Of Measure

hours

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Preserved source evidence · Not medical advice