NCT01849874 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of MEK162

A Study of MEK162 vs. Physician's Choice Chemotherapy in Patients With Low-grade Serous Ovarian, Fallopian Tube or Peritoneal Cancer · Source last updated 2023-10-30

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: Geometric Coefficient of Variation
Time frame: 2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.

What was measured

Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data.

Analysis population: The PK set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.

Groups in this outcome

MEK162

Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.

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
MEK162	52

Reported measurements

Week 1 (Study Day 1)

Analysis denominator · Participants

Group	Source count
MEK162	52

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MEK162	339	0.544	Not reported	Not reported	Not reported

Week 9 (Study Day 57)

Analysis denominator · Participants

Group	Source count
MEK162	30

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MEK162	343	0.959	Not reported	Not reported	Not reported

Week 17 (Study Day 113)

Analysis denominator · Participants

Group	Source count
MEK162	20

Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
Group	Value	Spread	Lower	Upper	Comment
MEK162	304	0.649	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.544
value
339
denoms
counts
group Id
OG000
value
52
units
Participants
title
Week 1 (Study Day 1)
categories
measurements
group Id
OG000
spread
0.959
value
343
denoms
counts
group Id
OG000
value
30
units
Participants
title
Week 9 (Study Day 57)
categories
measurements
group Id
OG000
spread
0.649
value
304
denoms
counts
group Id
OG000
value
20
units
Participants
title
Week 17 (Study Day 113)

denoms

counts
group Id
OG000
value
52
units
Participants

description

Cmax is maximum observed plasma concentration. Cmax of MEK162 was observed directly from data.

dispersion Type

Geometric Coefficient of Variation

groups

description
Participants received an oral dose of 45 milligram (mg) of MEK162 tablets (3 tablets of 15 mg) twice daily for each 28-day treatment cycle until disease progression, withdrawal of consent, initiation of subsequent anticancer therapy, lost to follow-up or death, whichever occurred first. Participants were followed up to 30 days after last dose of study intervention.
id
OG000
title
MEK162

param Type

GEOMETRIC_MEAN

population Description

The PK set consisted of all participants who received at least 1 dose of MEK162 and had at least 1 PK blood collection with associated bioanalytical results.

reporting Status

POSTED

time Frame

2 hours ± 10 minutes postdose on Study Days 1, 57, and 113.

title

Maximum Observed Plasma Concentration (Cmax) of MEK162

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice