TriangleNCT04607421 · OUTCOME
Cohort 3: ORR by Derived Investigator Assessment - FAS
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From date of randomization until documented PD, or start of subsequent anticancer therapy, or death, whichever occurred first (maximum up to 14.1 months)
What was measured
ORR was defined as the percentage of participants who achieved BOR of confirmed CR or PR according to RECIST v 1.1 by derived investigator assessment. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.
Analysis population: The FAS for Cohort 3 included all participants who were randomized in the Cohort 3 portion of the study, respectively.
Groups in this outcome
Cohort 3: Arm D [EC + FOLFIRI]
Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
Participants received fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
| Group | Source count |
|---|---|
| Cohort 3: Arm D [EC + FOLFIRI] | 73 |
| Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab] | 74 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Cohort 3: Arm D [EC + FOLFIRI] | 60.3 | Not reported | 48.8 | 70.7 | Not reported |
| Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab] | 40.5 | Not reported | 30.1 | 51.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 48.8
- upper Limit
- 70.7
- value
- 60.3
- group Id
- OG001
- lower Limit
- 30.1
- upper Limit
- 51.9
- value
- 40.5
- denoms
- counts
- group Id
- OG000
- value
- 73
- group Id
- OG001
- value
- 74
- units
- Participants
- description
- ORR was defined as the percentage of participants who achieved BOR of confirmed CR or PR according to RECIST v 1.1 by derived investigator assessment. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received encorafenib 300 mg QD orally and cetuximab 500 mg/m\^2 IV infusion for 120 minutes Q2W along with fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W. Participants received treatment in 28-day cycles.
- id
- OG000
- title
- Cohort 3: Arm D [EC + FOLFIRI]
- description
- Participants received fluorouracil 400 mg/m\^2 IV bolus then 2400 mg/m\^2 continuous IV infusion over 46-48 hours Q2W; leucovorin 400 mg/m\^2 IV infusion for 120 minutes Q2W and irinotecan 180 mg/m\^2 as IV infusion for 90 minutes Q2W with or without bevacizumab. Bevacizumab was optional and it was given per prescribing instructions of treating physician. Participants received treatment in 28-day cycles.
- id
- OG001
- title
- Cohort 3: Arm E [FOLFIRI With or Without Bevacizumab]
- param Type
- NUMBER
- population Description
- The FAS for Cohort 3 included all participants who were randomized in the Cohort 3 portion of the study, respectively.
- reporting Status
- POSTED
- time Frame
- From date of randomization until documented PD, or start of subsequent anticancer therapy, or death, whichever occurred first (maximum up to 14.1 months)
- title
- Cohort 3: ORR by Derived Investigator Assessment - FAS
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice