NCT01227889 · OUTCOME

Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma · Source last updated 2017-10-04

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: Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)

What was measured

PFS is defined as the interval of time between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause. Disease progression was based on radiographic or photographic evidence, and assessments were made by an independent radiologist according to RECIST version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started (e.g., percent change from nadir, where nadir is defined as the smallest sum of diameters recorded since treatment start). In addition, the sum must have an absolute increase from nadir of 5 mm. For participants who did not progress or die, PFS was censored at the date of last contact.

Analysis population: ITT Population

Groups in this outcome

GSK2118436 150 mg BID

Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.

DTIC 1000 mg/m^2 in RP

In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.

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
GSK2118436 150 mg BID	187
DTIC 1000 mg/m^2 in RP	63

Reported measurements

Source class 1

Values in Months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
GSK2118436 150 mg BID	6.7	Not reported	5.0	6.9	Not reported
DTIC 1000 mg/m^2 in RP	2.9	Not reported	1.7	4.9	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
0.20
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.61
estimate Comment
HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.35

Complete source fields

analyses

ci Lower Limit
0.20
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.61
estimate Comment
HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY_OR_OTHER
param Type
Hazard Ratio (HR)
param Value
0.35

classes

categories
measurements
group Id
OG000
lower Limit
5.0
upper Limit
6.9
value
6.7
group Id
OG001
lower Limit
1.7
upper Limit
4.9
value
2.9

denoms

counts
group Id
OG000
value
187
group Id
OG001
value
63
units
Participants

description

dispersion Type

95% Confidence Interval

groups

description
Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
id
OG000
title
GSK2118436 150 mg BID
description
In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
id
OG001
title
DTIC 1000 mg/m^2 in RP

param Type

MEDIAN

population Description

ITT Population

reporting Status

POSTED

time Frame

Time interval between the date of randomization and the earlier of the date of disease progression or the date of death due to any cause (up to 9.9 months)

title

Progression-free Survival (PFS) as Assessed by an Independent Radiologist: Randomized Phase

type

PRIMARY

unit Of Measure

Months

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Preserved source evidence · Not medical advice