TriangleNCT01909453 · OUTCOME
Part 2: PFS by BIRC in Combo 300 Group as Compared to LGX818 Group
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 documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)
What was measured
PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
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 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 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 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 12.9 | Not reported | 10.1 | 14.0 | Not reported |
| Part 2: LGX818 300 mg | 7.4 | Not reported | 5.6 | 9.2 | Not reported |
| Part 1 + Part 2: LGX818 300 mg | 9.2 | Not reported | 7.4 | 11.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10.1
- upper Limit
- 14.0
- value
- 12.9
- group Id
- OG001
- lower Limit
- 5.6
- upper Limit
- 9.2
- value
- 7.4
- group Id
- OG002
- lower Limit
- 7.4
- upper Limit
- 11.0
- value
- 9.2
- denoms
- counts
- group Id
- OG000
- value
- 258
- group Id
- OG001
- value
- 86
- group Id
- OG002
- value
- 280
- units
- Participants
- description
- PFS was defined as the time from the date of randomization to the date of the first documented PD or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm\^2.
- dispersion Type
- 95% Confidence Interval
- groups
- 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
- OG000
- 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
- OG001
- 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
- OG002
- 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 documented PD, initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)
- title
- Part 2: PFS by BIRC in Combo 300 Group as Compared to LGX818 Group
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice