NCT00863655 · OUTCOME

Exemestane Concentrations at Week 4

Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole · Source last updated 2017-05-02

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: predose, 2 hours post-dose

What was measured

Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.

Analysis population: Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

Groups in this outcome

Everolimus + Exemestane

Everolimus 10 mg daily in combination with exemestane 25 mg daily

Placebo + Exemestane

Placebo of everolimus in combination with exemestane 25 mg daily

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
Everolimus + Exemestane	39
Placebo + Exemestane	22

Reported measurements

Pre-dose (Cmin) (n: 34, n: 22)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + Exemestane	0.63	0.474	1.00	1.00	Not reported
Placebo + Exemestane	0.43	0.376	NA	NA	Not reported

2 hours post-dose (C2h) (n: 39, n: 22)

Values in ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Everolimus + Exemestane	23.16	19.805	0.68	0.94	Not reported
Placebo + Exemestane	13.30	11.889	NA	NA	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
1.00
spread
0.474
upper Limit
1.00
value
0.63
group Id
OG001
lower Limit
NA
spread
0.376
upper Limit
NA
value
0.43
title
Pre-dose (Cmin) (n: 34, n: 22)
categories
measurements
group Id
OG000
lower Limit
0.68
spread
19.805
upper Limit
0.94
value
23.16
group Id
OG001
lower Limit
NA
spread
11.889
upper Limit
NA
value
13.30
title
2 hours post-dose (C2h) (n: 39, n: 22)

denoms

counts
group Id
OG000
value
39
group Id
OG001
value
22
units
Participants

description

Characterize the PK of exemestane in combination with or without everolimus using Cmin and C2h at week 4 in a small group of patients.

dispersion Type

Standard Deviation

groups

description
Everolimus 10 mg daily in combination with exemestane 25 mg daily
id
OG000
title
Everolimus + Exemestane
description
Placebo of everolimus in combination with exemestane 25 mg daily
id
OG001
title
Placebo + Exemestane

param Type

MEAN

population Description

Safety Set population consisted of all patients who received at least one dose of study treatment and who had at least one valid post-baseline safety assessment. Although the safety set was considered for the analysis (N), only participants (n) who had pre-dose \& 2 hours post-dose values for the given time points were analyzed for that time point.

reporting Status

POSTED

time Frame

predose, 2 hours post-dose

title

Exemestane Concentrations at Week 4

type

SECONDARY

unit Of Measure

ng/mL

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

Preserved source evidence · Not medical advice