NCT05198934 · OUTCOME
Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR
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
- From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months
What was measured
PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
Analysis population: FAS included all randomized participants.
Groups in this outcome
Trifluridine and Tipiracil or Regorafenib
Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
Sotorasib 240 mg + Panitumumab
Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
Sotorasib 960 mg + Panitumumab
Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
| Group | Source count |
|---|---|
| Trifluridine and Tipiracil or Regorafenib | 54 |
| Sotorasib 240 mg + Panitumumab | 53 |
| Sotorasib 960 mg + Panitumumab | 53 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Trifluridine and Tipiracil or Regorafenib | 2.04 | Not reported | 1.91 | 3.91 | Not reported |
| Sotorasib 240 mg + Panitumumab | 3.91 | Not reported | 3.61 | 5.75 | Not reported |
| Sotorasib 960 mg + Panitumumab | 5.62 | Not reported | 4.21 | 6.31 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.91
- upper Limit
- 3.91
- value
- 2.04
- group Id
- OG001
- lower Limit
- 3.61
- upper Limit
- 5.75
- value
- 3.91
- group Id
- OG002
- lower Limit
- 4.21
- upper Limit
- 6.31
- value
- 5.62
- denoms
- counts
- group Id
- OG000
- value
- 54
- group Id
- OG001
- value
- 53
- group Id
- OG002
- value
- 53
- units
- Participants
- description
- PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received investigator's choice of trifluridine and tipiracil or regorafenib. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
- id
- OG000
- title
- Trifluridine and Tipiracil or Regorafenib
- description
- Participants received sotorasib 240 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
- id
- OG001
- title
- Sotorasib 240 mg + Panitumumab
- description
- Participants received sotorasib 960 mg QD in combination with panitumumab. Treatment continued until progressive disease, intolerance to treatment necessitating treatment discontinuation, need for other anticancer therapy, withdrawal of consent, or death.
- id
- OG002
- title
- Sotorasib 960 mg + Panitumumab
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until DCO or death; median (min, max) time on trial was 6.23 (0.1, 14.0) months
- title
- Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 as Assessed by BICR
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Independent clinical review pending · Not medical advice
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