NCT01136733 · OUTCOME

Time to Cmax (Tmax) for Everolimus 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: MEDIAN
Unit: Hours
Interval / dispersion: Full Range
Time frame: Phase 2: Cycle 1 Day 15

What was measured

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

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 Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Phase 2: 18 mg Lenvatinib + 5 mg Everolimus	1.0	Not reported	0.5	8.0	Not reported
Phase 2: 10 mg Everolimus	1.0	Not reported	0.5	25.9	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.5
upper Limit
8.0
value
1.0
group Id
OG001
lower Limit
0.5
upper Limit
25.9
value
1.0

denoms

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

description

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

dispersion Type

Full Range

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

MEDIAN

population Description

PK sub analysis set

reporting Status

POSTED

time Frame

Phase 2: Cycle 1 Day 15

title

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

type

SECONDARY

unit Of Measure

Hours

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

Preserved source evidence · Not medical advice