NCT01136733 · OUTCOME

Maximum Concentration of Everolimus (Cmax) in Blood When Administered Alone or in Combination With Lenvatinib

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: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Phase 2: Cycle 1 Day 15

What was measured

Cmax for everolimus was defined as the maximum observed concentration of everolimus in blood following administration of study treatment on Cycle 1 Day 15 and was obtained directly from the measured blood concentration-time curves.

Analysis population: PK sub analysis set

Groups in this outcome

Phase 2: 18 mg Lenvatinib + 5 mg Everolimus

Oral lenvatinib (18 mg) 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: 10 mg Everolimus

Oral everolimus (10 mg) was taken once daily in the morning (consistently either 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

Group	Source count
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus	4
Phase 2: 10 mg Everolimus	11

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus	38	14.5	Not reported	Not reported	Not reported
Phase 2: 10 mg Everolimus	54	24.9	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
14.5
value
38
group Id
OG001
spread
24.9
value
54

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
11
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Oral lenvatinib (18 mg) 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
description
Oral everolimus (10 mg) was taken once daily in the morning (consistently either with or without food) with water, in continuous 28-day (4-week) cycles.
id
OG001
title
Phase 2: 10 mg Everolimus

param Type

MEAN

population Description

PK sub analysis set

reporting Status

POSTED

time Frame

Phase 2: Cycle 1 Day 15

title

Maximum Concentration of Everolimus (Cmax) in Blood When Administered Alone or in Combination With Lenvatinib

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice