TriangleNCT01909453 · OUTCOME
Part 1 and Part 2: Time to Definitive 1 Point Deterioration in ECOG PS
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
- Baseline up to 30 days from last dose of study drug (up to 30 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 36 months for Part 2 and Part 1 LGX 300 mg group)
What was measured
ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. Definitive deterioration was defined as death due to any cause or decrease in ECOG PS by at least one category from baseline score with no subsequent improvement. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
Analysis population: Safety analysis set includes all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
Groups in this outcome
Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: LGX818 300 mg
Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: Vemurafenib 960 mg BID
Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 2: LGX818 300 mg
Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1 + Part 2: LGX818 300 mg
Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
| Group | Source count |
|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 192 |
| Part 1: LGX818 300 mg | 187 |
| Part 1: Vemurafenib 960 mg BID | 185 |
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 257 |
| Part 2: LGX818 300 mg | 83 |
| Part 1 + Part 2: LGX818 300 mg | 270 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | NA | Not reported | 23.0 | NA | Median and upper limit of 95% CI were not estimable due to low number of participants with events. |
| Part 1: LGX818 300 mg | 26.7 | Not reported | 14.8 | NA | Upper limit of 95% CI was not estimable due to low number of participants with events. |
| Part 1: Vemurafenib 960 mg BID | 18.2 | Not reported | 11.1 | NA | Upper limit of 95% CI was not estimable due to low number of participants with events. |
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | NA | Not reported | NA | NA | Median and 95% CI were not estimable due to low number of participants with events. |
| Part 2: LGX818 300 mg | 10.2 | Not reported | 8.1 | NA | Upper limit of 95% CI was not estimable due to low number of participants with events. |
| Part 1 + Part 2: LGX818 300 mg | 19.2 | Not reported | 12.9 | NA | Upper limit of 95% CI was not estimable due to low number of participants with events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI were not estimable due to low number of participants with events.
- group Id
- OG000
- lower Limit
- 23.0
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG001
- lower Limit
- 14.8
- upper Limit
- NA
- value
- 26.7
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG002
- lower Limit
- 11.1
- upper Limit
- NA
- value
- 18.2
- comment
- Median and 95% CI were not estimable due to low number of participants with events.
- group Id
- OG003
- lower Limit
- NA
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG004
- lower Limit
- 8.1
- upper Limit
- NA
- value
- 10.2
- comment
- Upper limit of 95% CI was not estimable due to low number of participants with events.
- group Id
- OG005
- lower Limit
- 12.9
- upper Limit
- NA
- value
- 19.2
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 187
- group Id
- OG002
- value
- 185
- group Id
- OG003
- value
- 257
- group Id
- OG004
- value
- 83
- group Id
- OG005
- value
- 270
- units
- Participants
- description
- ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50% of waking hours; 3= capable of only limited self-care, confined to bed/chair \>50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. Definitive deterioration was defined as death due to any cause or decrease in ECOG PS by at least one category from baseline score with no subsequent improvement. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG000
- title
- Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- description
- Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG001
- title
- Part 1: LGX818 300 mg
- description
- Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG002
- title
- Part 1: Vemurafenib 960 mg BID
- description
- Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG003
- title
- Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
- description
- Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG004
- title
- Part 2: LGX818 300 mg
- description
- Participants of Part 1 and 2 received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, and study discontinuation, lost to follow-up or death.
- id
- OG005
- title
- Part 1 + Part 2: LGX818 300 mg
- param Type
- MEDIAN
- population Description
- Safety analysis set includes all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days from last dose of study drug (up to 30 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 36 months for Part 2 and Part 1 LGX 300 mg group)
- title
- Part 1 and Part 2: Time to Definitive 1 Point Deterioration in ECOG PS
- type
- SECONDARY
- unit Of Measure
- Months
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Preserved source evidence · Not medical advice