TriangleNCT04256707 · OUTCOME
Combination Therapy (Arm C): Percentage of Participants With ORR as Assessed by RECIST 1.1
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
- Up to 25 months
What was measured
ORR was defined as the proportion of participants who achieve an Investigator-determined BOR of PR or CR as assessed by RECIST or iRECIST before disease progression or initiating a new antineoplastic treatment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) might have reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Analysis population: MITT population for the combination period included all participants who received at least 1 dose of selinexor in the combination therapy period.
Groups in this outcome
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
| Group | Source count |
|---|---|
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 6 |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 2 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 0 | Not reported | 0 | 0 | Not reported |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 0 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 2
- units
- Participants
- description
- ORR was defined as the proportion of participants who achieve an Investigator-determined BOR of PR or CR as assessed by RECIST or iRECIST before disease progression or initiating a new antineoplastic treatment. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) might have reduction in the short axis to \<10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with colorectal cancer received selinexor 40 mg orally on Days 1, 3, 15 and 18 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5- fluorouracil (5-FU) 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
- id
- OG000
- title
- Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1)
- description
- Participants with colorectal cancer received selinexor 80 mg orally on Days 1 and 15 in a 28-day cycle and FOLFIRI (irinotecan 180 mg/m\^2; leucovorin 400 mg/m\^2; 5-FU 400 mg/m\^2 bolus then 5-FU 2400 mg/m\^2 continuous over 46-48 hours; IV on Day 1 and 15 in a 28-day cycle) until PD or intolerable toxicity up to 25 months.
- id
- OG001
- title
- Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
- param Type
- NUMBER
- population Description
- MITT population for the combination period included all participants who received at least 1 dose of selinexor in the combination therapy period.
- reporting Status
- POSTED
- time Frame
- Up to 25 months
- title
- Combination Therapy (Arm C): Percentage of Participants With ORR as Assessed by RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice