TriangleNCT01909453 · OUTCOME
Part 1 and Part 2: Time to Objective Response (TTR)
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
- From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
What was measured
TTR was the time between date of randomization until first documented response of CR or PR. Participants who did not achieve a PR or CR were censored at the last adequate tumor assessment date when they did not have a PFS event or at maximum follow-up (i.e. first patient first visit \[FPFV\] to last patient last visit \[LPLV\] used for the analysis) when they had a PFS event. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. TTR was estimated in the treatment arms using a Kaplan-Meier method. TTR was based on central review. All collected data up to the pre-specified collection period (i.e., end of study) are reported for this outcome measure.
Analysis population: FAS included all randomized participants. 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 | 194 |
| Part 1: Vemurafenib 960 mg BID | 191 |
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 258 |
| Part 2: LGX818 300 mg | 86 |
| Part 1 + Part 2: LGX818 300 mg | 280 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 1.9 | Not reported | 1.9 | 1.9 | Not reported |
| Part 1: LGX818 300 mg | 2.0 | Not reported | 1.9 | 3.6 | Not reported |
| Part 1: Vemurafenib 960 mg BID | 2.1 | Not reported | 1.9 | 3.7 | Not reported |
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 1.9 | Not reported | 1.9 | 2.0 | Not reported |
| Part 2: LGX818 300 mg | 1.9 | Not reported | 1.9 | 2.3 | Not reported |
| Part 1 + Part 2: LGX818 300 mg | 1.9 | Not reported | 1.9 | 3.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.9
- upper Limit
- 1.9
- value
- 1.9
- group Id
- OG001
- lower Limit
- 1.9
- upper Limit
- 3.6
- value
- 2.0
- group Id
- OG002
- lower Limit
- 1.9
- upper Limit
- 3.7
- value
- 2.1
- group Id
- OG003
- lower Limit
- 1.9
- upper Limit
- 2.0
- value
- 1.9
- group Id
- OG004
- lower Limit
- 1.9
- upper Limit
- 2.3
- value
- 1.9
- group Id
- OG005
- lower Limit
- 1.9
- upper Limit
- 3.2
- value
- 1.9
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 194
- group Id
- OG002
- value
- 191
- group Id
- OG003
- value
- 258
- group Id
- OG004
- value
- 86
- group Id
- OG005
- value
- 280
- units
- Participants
- description
- TTR was the time between date of randomization until first documented response of CR or PR. Participants who did not achieve a PR or CR were censored at the last adequate tumor assessment date when they did not have a PFS event or at maximum follow-up (i.e. first patient first visit \[FPFV\] to last patient last visit \[LPLV\] used for the analysis) when they had a PFS event. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. TTR was estimated in the treatment arms using a Kaplan-Meier method. TTR was based on central review. 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
- FAS included all randomized participants. It was planned to report combined result data of Part 1 and Part 2 for LGX818 300 mg arm.
- reporting Status
- POSTED
- time Frame
- From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
- title
- Part 1 and Part 2: Time to Objective Response (TTR)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice