NCT01327053 · OUTCOME

Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)

A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma · Source last updated 2019-08-28

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: Months
Interval / dispersion: 95% Confidence Interval
Time frame: 42 months

What was measured

Progression-free survival (PFS) is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause. If a patient has not had an event, progression-free survival is censored at the date of last adequate tumor assessment.

Analysis population: The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, \& including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.

Groups in this outcome

LDE225 200mg laBCC

The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 800mg laBCC

The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 200mg mBCC

The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

LDE225 800mg mBCC

The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.

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
LDE225 200mg laBCC	42
LDE225 800mg laBCC	93
LDE225 200mg mBCC	13
LDE225 800mg mBCC	23

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
LDE225 200mg laBCC	19.0	Not reported	NA	NA	N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed.
LDE225 800mg laBCC	19.4	Not reported	13.8	30.5	Not reported
LDE225 200mg mBCC	13.1	Not reported	5.6	33.1	Not reported
LDE225 800mg mBCC	11.1	Not reported	7.3	16.6	Not reported

Complete source fields

classes

categories
measurements
comment
N/A = Both lower and upper confidence intervals were not estimable as limited numbers of PD or death were observed.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
19.0
group Id
OG001
lower Limit
13.8
upper Limit
30.5
value
19.4
group Id
OG002
lower Limit
5.6
upper Limit
33.1
value
13.1
group Id
OG003
lower Limit
7.3
upper Limit
16.6
value
11.1

denoms

counts
group Id
OG000
value
42
group Id
OG001
value
93
group Id
OG002
value
13
group Id
OG003
value
23
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
id
OG000
title
LDE225 200mg laBCC
description
The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
id
OG001
title
LDE225 800mg laBCC
description
The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
id
OG002
title
LDE225 200mg mBCC
description
The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
id
OG003
title
LDE225 800mg mBCC

param Type

MEDIAN

population Description

The primary efficacy analysis set (pEAS) was a subset of the full analysis set (FAS) including patients with laBCC with tumors that were adequately assessed by MRI or photography or both, \& including all patients with mBCC included in the FAS which comprised all patients who were assigned study treatment irrespective of receiving it.

reporting Status

POSTED

time Frame

42 months

title

Progression-free Survival (PFS) Per Central Review Using mRECIST for laBCC and RECIST 1.1 for mBCC (pEAS)

type

SECONDARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice