TriangleNCT04256707 · OUTCOME
Combination Therapy (Arms: A, B and C): Progression-free Survival (PFS)
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 from starting date of combination therapy until the date of first PD or death due to any case, whichever occurs first (up to 25 months)
What was measured
PFS was defined as the time from the starting date of the combination therapy until the date of first progressive disease (PD) determined by PI per Response Evaluation Criteria in Solid Tumors (RECIST) for Arm A and B or Immunotherapeutic Response Evaluation Criteria in Solid Tumors (iRECIST) for Arm C, or death due to any cause, whichever occurred first.
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: 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 | 5.78 | Not reported | 3.15 | NA | Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events. |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 1.97 | Not reported | 1.91 | 3.94 | Not reported |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 1.86 | Not reported | 1.54 | NA | Upper limit of 95% CI was not estimable due to insufficient number of events. |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 2.76 | Not reported | 1.71 | NA | Upper limit of 95% CI was not estimable due to insufficient number of events. |
Complete source fields
- classes
- categories
- measurements
- comment
- Upper limit of 95% confidence interval (CI) was not estimable due to insufficient number of events.
- group Id
- OG000
- lower Limit
- 3.15
- upper Limit
- NA
- value
- 5.78
- group Id
- OG001
- lower Limit
- 1.91
- upper Limit
- 3.94
- value
- 1.97
- comment
- Upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG002
- lower Limit
- 1.54
- upper Limit
- NA
- value
- 1.86
- comment
- Upper limit of 95% CI was not estimable due to insufficient number of events.
- group Id
- OG003
- lower Limit
- 1.71
- upper Limit
- NA
- value
- 2.76
- 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
- PFS was defined as the time from the starting date of the combination therapy until the date of first progressive disease (PD) determined by PI per Response Evaluation Criteria in Solid Tumors (RECIST) for Arm A and B or Immunotherapeutic Response Evaluation Criteria in Solid Tumors (iRECIST) for Arm C, or death due to any cause, whichever occurred first.
- 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 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
- Time from starting date of combination therapy until the date of first PD or death due to any case, whichever occurs first (up to 25 months)
- title
- Combination Therapy (Arms: A, B and C): Progression-free Survival (PFS)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice