TriangleNCT04256707 · OUTCOME
Combination Therapy (Arms: A and B): Overall Response Rate (ORR) as Assessed by Response Criteria in Solid Tumors Version 1.1 (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
Overall response rate (ORR) was defined as the percentage of participants who achieved an Investigator-determined best overall response (BOR) of partial response (PR) or complete response (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. Percentage of participants who achieved ORR were reported.
Analysis population: Modified Intent-to-treat (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.
| Group | Source count |
|---|---|
| Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel | 17 |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 38 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Combination Therapy: NSCLC Arm A: Selinexor + Docetaxel | 11.8 | Not reported | 1.5 | 36.4 | Not reported |
| Combination Therapy: CRC Arm B: Selinexor + Pembrolizumab | 0 | Not reported | 0 | 0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 36.4
- value
- 11.8
- group Id
- OG001
- lower Limit
- 0
- upper Limit
- 0
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 38
- units
- Participants
- description
- Overall response rate (ORR) was defined as the percentage of participants who achieved an Investigator-determined best overall response (BOR) of partial response (PR) or complete response (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. Percentage of participants who achieved ORR were reported.
- 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
- param Type
- NUMBER
- population Description
- Modified Intent-to-treat (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 (Arms: A and B): Overall Response Rate (ORR) as Assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
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Preserved source evidence · Not medical advice