NCT03881488 · OUTCOME
Progression-free Survival
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- From the first dose of CTX-471 to progression of disease or death
What was measured
Time from the first dose of CTX-471 to disease progression (as assessed by Response Evaluation Criteria in Solid Tumours guideline version 1.1) or death
Analysis population: Response Evaluable Analysis Set: all patients with measurable disease before treatment who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment response assessment or discontinued treatment due to progression of disease progression within 8 weeks after first dose of study treatment.
Groups in this outcome
CTX-471 Monotherapy 0.1 mg/kg
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 0.3 mg/kg
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 0.6 mg/kg
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Monotherapy 1.2 mg/kg
1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
CTX-471 Combination 0.1 mg/kg
0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
CTX-471 Combination 0.3 mg/kg
0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
CTX-471 Combination 0.6 mg/kg
0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
| Group | Source count |
|---|---|
| CTX-471 Monotherapy 0.1 mg/kg | 3 |
| CTX-471 Monotherapy 0.3 mg/kg | 31 |
| CTX-471 Monotherapy 0.6 mg/kg | 33 |
| CTX-471 Monotherapy 1.2 mg/kg | 4 |
| CTX-471 Combination 0.1 mg/kg | 3 |
| CTX-471 Combination 0.3 mg/kg | 8 |
| CTX-471 Combination 0.6 mg/kg | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CTX-471 Monotherapy 0.1 mg/kg | 3.55 | Not reported | 1.64 | 5.49 | Not reported |
| CTX-471 Monotherapy 0.3 mg/kg | 3.55 | Not reported | 0.95 | 42.07 | Not reported |
| CTX-471 Monotherapy 0.6 mg/kg | 3.52 | Not reported | 1.51 | 14.77 | Not reported |
| CTX-471 Monotherapy 1.2 mg/kg | 3.05 | Not reported | 1.74 | 4.21 | Not reported |
| CTX-471 Combination 0.1 mg/kg | 1.84 | Not reported | 1.58 | 20.53 | Not reported |
| CTX-471 Combination 0.3 mg/kg | 2.89 | Not reported | 1.64 | 14.77 | Not reported |
| CTX-471 Combination 0.6 mg/kg | 2.36 | Not reported | 1.18 | 3.68 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.64
- upper Limit
- 5.49
- value
- 3.55
- group Id
- OG001
- lower Limit
- 0.95
- upper Limit
- 42.07
- value
- 3.55
- group Id
- OG002
- lower Limit
- 1.51
- upper Limit
- 14.77
- value
- 3.52
- group Id
- OG003
- lower Limit
- 1.74
- upper Limit
- 4.21
- value
- 3.05
- group Id
- OG004
- lower Limit
- 1.58
- upper Limit
- 20.53
- value
- 1.84
- group Id
- OG005
- lower Limit
- 1.64
- upper Limit
- 14.77
- value
- 2.89
- group Id
- OG006
- lower Limit
- 1.18
- upper Limit
- 3.68
- value
- 2.36
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 31
- group Id
- OG002
- value
- 33
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 8
- group Id
- OG006
- value
- 9
- units
- Participants
- description
- Time from the first dose of CTX-471 to disease progression (as assessed by Response Evaluation Criteria in Solid Tumours guideline version 1.1) or death
- dispersion Type
- Full Range
- groups
- description
- 0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- OG000
- title
- CTX-471 Monotherapy 0.1 mg/kg
- description
- 0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- OG001
- title
- CTX-471 Monotherapy 0.3 mg/kg
- description
- 0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- OG002
- title
- CTX-471 Monotherapy 0.6 mg/kg
- description
- 1.2 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks
- id
- OG003
- title
- CTX-471 Monotherapy 1.2 mg/kg
- description
- 0.1 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- OG004
- title
- CTX-471 Combination 0.1 mg/kg
- description
- 0.3 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- OG005
- title
- CTX-471 Combination 0.3 mg/kg
- description
- 0.6 mg/kg body weight of CTX-471 by IV infusion over 1 hour every 2 weeks + 400 mg of pembrolizumab by IV infusion over 30 minutes every 6 weeks
- id
- OG006
- title
- CTX-471 Combination 0.6 mg/kg
- param Type
- MEDIAN
- population Description
- Response Evaluable Analysis Set: all patients with measurable disease before treatment who received CTX-471 (and pembrolizumab in combination arms) and had at least 1 post-treatment response assessment or discontinued treatment due to progression of disease progression within 8 weeks after first dose of study treatment.
- reporting Status
- POSTED
- time Frame
- From the first dose of CTX-471 to progression of disease or death
- title
- Progression-free Survival
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-d643ffaf417bcef6d45eb5e0
Preserved source evidence · Not medical advice
Triangle