TriangleNCT04256707 · OUTCOME
Combination Therapy (Arms: A, B and C): Overall Survival (OS)
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
- Time since the starting date of combination therapy until death due to any cause (up to 25 months)
What was measured
OS was defined as time since the starting date of the combination therapy until death due to any cause.
Analysis population: MITT population included all participants who received at least 1 dose of selinexor in the combination therapy period.
Groups in this outcome
Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel
Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.
Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab
Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.
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: NSCLC Arm A: Selinexor + Docetaxel | 17 |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 38 |
| 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: NSCLC Arm A: Selinexor + Docetaxel | 6.01 | Not reported | 5.49 | NA | The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary. |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 8.25 | Not reported | 7.03 | 11.70 | Not reported |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 4.76 | Not reported | 4.14 | NA | The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary. |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 6.83 | Not reported | 5.06 | NA | The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary. |
Complete source fields
- classes
- categories
- measurements
- comment
- The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary.
- group Id
- OG000
- lower Limit
- 5.49
- upper Limit
- NA
- value
- 6.01
- group Id
- OG001
- lower Limit
- 7.03
- upper Limit
- 11.70
- value
- 8.25
- comment
- The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary.
- group Id
- OG002
- lower Limit
- 4.14
- upper Limit
- NA
- value
- 4.76
- comment
- The upper 95% CI was not estimable due to insufficient events to determine the upper confidence boundary.
- group Id
- OG003
- lower Limit
- 5.06
- upper Limit
- NA
- value
- 6.83
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 38
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 2
- units
- Participants
- description
- OS was defined as time since the starting date of the combination therapy until death due to any cause.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants with non-small cell lung cancer received selinexor 60 mg orally QW and docetaxel 75 mg/m\^2 IV for every 3 weeks until PD or intolerable toxicity.
- id
- OG000
- title
- Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel
- description
- Participants with colorectal cancer received selinexor 80 mg orally QW and pembrolizumab 200 mg IV every 3 weeks until PD or intolerable toxicity.
- id
- OG001
- title
- Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab
- 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
- OG002
- 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
- OG003
- title
- Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2)
- param Type
- MEDIAN
- population Description
- MITT population included all participants who received at least 1 dose of selinexor in the combination therapy period.
- reporting Status
- POSTED
- time Frame
- Time since the starting date of combination therapy until death due to any cause (up to 25 months)
- title
- Combination Therapy (Arms: A, B and C): Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice