TriangleNCT04256707 · OUTCOME
Combination Therapy (Arms: A, B and C): Duration of Response (DOR)
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
- Date of first PR or better to the date of first PD or death due to any cause, whichever occurs first (up to 25 months)
What was measured
DOR was defined for participants with partial response (PR) or complete response (CR) as the duration from the date of first PR or better to the date of first PD or death due to any cause, whichever occurred first. 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. No participants in the CRC Arm B and Arm C achieved CR or PR, therefore, the duration of response could not be calculated for this arm.
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 | 1 |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 0 |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 1) | 0 |
| Combination Therapy: CRC Arm C: Selinexor + FOLFIRI (Cohort 2) | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel | 14.49 | Not reported | NA | NA | Lower and upper limit of 95% CI was not estimable due to single participant. |
Complete source fields
- classes
- categories
- measurements
- comment
- Lower and upper limit of 95% CI was not estimable due to single participant.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 14.49
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- DOR was defined for participants with partial response (PR) or complete response (CR) as the duration from the date of first PR or better to the date of first PD or death due to any cause, whichever occurred first. 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 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. No participants in the CRC Arm B and Arm C achieved CR or PR, therefore, the duration of response could not be calculated for this arm.
- reporting Status
- POSTED
- time Frame
- Date of first PR or better to the date of first PD or death due to any cause, whichever occurs first (up to 25 months)
- title
- Combination Therapy (Arms: A, B and C): Duration of Response (DOR)
- type
- SECONDARY
- unit Of Measure
- months
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Preserved source evidence · Not medical advice