NCT01136733 · OUTCOME

Summary of Plasma Concentrations of Lenvatinib for Sparse Pharmacokinetic (PK) Sampling for Phase 1b and Phase 2

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: GEOMETRIC_MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)

What was measured

Blood samples were collected during the Randomization Phase. Most participants had 6 samples taken over 3 cycles of treatment (sparse sampling - 2 samples taken per cycle, one at predose and one at 2 to 8 hours postdose). Plasma concentrations of lenvatinib were measured and concentration data were summarized. The summary statistics at time points with one or more below the limit of quantitation (BLQ) values were calculated by assigning zero for each BLQ value.

Analysis population: Pharmacokinetic analysis set included all participants who have received at least one dose of study drug (lenvatinib or everolimus) and have evaluable concentration data.

Groups in this outcome

Cycle 1, Day 1 (0 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.

Cycle 1, Day 1 (2-8 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.

Cycle 2, Day 1 (0 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.

Cycle 2, Day 1 (2-8 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.

Cycle 3, Day 1 (0 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.

Cycle 3, Day 1 (2-8 Hours)

Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.

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
Cycle 1, Day 1 (0 Hours)	57
Cycle 1, Day 1 (2-8 Hours)	55
Cycle 2, Day 1 (0 Hours)	45
Cycle 2, Day 1 (2-8 Hours)	41
Cycle 3, Day 1 (0 Hours)	42
Cycle 3, Day 1 (2-8 Hours)	40

Reported measurements

Source class 1

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cycle 1, Day 1 (0 Hours)	5.6	29.8	Not reported	Not reported	Not reported
Cycle 1, Day 1 (2-8 Hours)	197	140	Not reported	Not reported	Not reported
Cycle 2, Day 1 (0 Hours)	66.9	52.7	Not reported	Not reported	Not reported
Cycle 2, Day 1 (2-8 Hours)	237	154	Not reported	Not reported	Not reported
Cycle 3, Day 1 (0 Hours)	37.0	35.5	Not reported	Not reported	Not reported
Cycle 3, Day 1 (2-8 Hours)	180	118	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
29.8
value
5.6
group Id
OG001
spread
140
value
197
group Id
OG002
spread
52.7
value
66.9
group Id
OG003
spread
154
value
237
group Id
OG004
spread
35.5
value
37.0
group Id
OG005
spread
118
value
180

denoms

counts
group Id
OG000
value
57
group Id
OG001
value
55
group Id
OG002
value
45
group Id
OG003
value
41
group Id
OG004
value
42
group Id
OG005
value
40
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
id
OG000
title
Cycle 1, Day 1 (0 Hours)
description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
id
OG001
title
Cycle 1, Day 1 (2-8 Hours)
description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
id
OG002
title
Cycle 2, Day 1 (0 Hours)
description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
id
OG003
title
Cycle 2, Day 1 (2-8 Hours)
description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected immediately prior to study drug administration.
id
OG004
title
Cycle 3, Day 1 (0 Hours)
description
Lenvatinib (18 mg) and everolimus (5 mg) were administered as described previously. Blood samples were collected 2 to 8 hours after study drug administration.
id
OG005
title
Cycle 3, Day 1 (2-8 Hours)

param Type

GEOMETRIC_MEAN

population Description

Pharmacokinetic analysis set included all participants who have received at least one dose of study drug (lenvatinib or everolimus) and have evaluable concentration data.

reporting Status

POSTED

time Frame

Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 3 (Day 1)

title

Summary of Plasma Concentrations of Lenvatinib for Sparse Pharmacokinetic (PK) Sampling for Phase 1b and Phase 2

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice