TriangleNCT04442126 · OUTCOME
To Determine the Anti-tumor Activity (Progression-free Survival) of NM21-1480 According to RECIST 1.1
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 baseline to up to 12 weeks post last dose, up to 48 weeks.
Analysis population: Progression-Free Survival (PFS) is defined as the time from the start of study treatment until the earliest documented date of disease progression or death. \[1\] Q1, Median and Q3 are Kaplan-Meier estimates and the 2-sided 95% confidence interval for median is calculated using the Brookmeyer-Crowley method.
Groups in this outcome
Part A Dose Level 1 NM21-1480-Q2W 0.15mg
Flat dose level; 0.15mg (Dose Level 1)
Part A Dose Level 2 NM21-1480-Q2W 1.5mg
Flat dose level; 1.5mg (Dose Level 2)
Part A Dose Level 3 NM21-1480-Q2W 8mg
Flat dose level; 8mg (Dose Level 3)
Part A Dose Level 4 NM21-1480-Q2W 24mg
Flat dose level; 24mg (Dose Level 4)
Part A Dose Level 5 NM21-1480-Q2W 80mg
Flat dose level; 80mg (Dose Level 5)
Part A Dose Level 6 NM21-1480-Q2W 240mg
Flat dose level; 240mg (Dose Level 6)
Part A Dose Level 7 NM21-1480-Q2W 800mg
Flat dose level; mg800 (Dose Level 7)
Part A2 NM21-1480-Q2W
This part of the study consisted of a 1400mg flat dose across one cohort.
Part B NM21-1480-Q2W
This part of the study consisted of a 800mg flat dose across three cohorts.
| Group | Source count |
|---|---|
| Part A Dose Level 1 NM21-1480-Q2W 0.15mg | 0 |
| Part A Dose Level 2 NM21-1480-Q2W 1.5mg | 0 |
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 3 |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 3 |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 5 |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 2 |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 7 |
| Part A2 NM21-1480-Q2W | 0 |
| Part B NM21-1480-Q2W | 19 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part A Dose Level 3 NM21-1480-Q2W 8mg | 1.84 | Not reported | 1.708 | 3.253 | Not reported |
| Part A Dose Level 4 NM21-1480-Q2W 24mg | 5.49 | Not reported | 5.454 | 5.552 | Not reported |
| Part A Dose Level 5 NM21-1480-Q2W 80mg | 1.81 | Not reported | 0.657 | 9.002 | Not reported |
| Part A Dose Level 6 NM21-1480-Q2W 240mg | 7.28 | Not reported | 3.548 | 11.006 | Not reported |
| Part A Dose Level 7 NM21-1480-Q2W 800mg | 2.86 | Not reported | 1.314 | 7.261 | Not reported |
| Part B NM21-1480-Q2W | 1.41 | Not reported | 0.0526 | 2.727 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 1.708
- upper Limit
- 3.253
- value
- 1.84
- group Id
- OG003
- lower Limit
- 5.454
- upper Limit
- 5.552
- value
- 5.49
- group Id
- OG004
- lower Limit
- 0.657
- upper Limit
- 9.002
- value
- 1.81
- group Id
- OG005
- lower Limit
- 3.548
- upper Limit
- 11.006
- value
- 7.28
- group Id
- OG006
- lower Limit
- 1.314
- upper Limit
- 7.261
- value
- 2.86
- group Id
- OG008
- lower Limit
- 0.0526
- upper Limit
- 2.727
- value
- 1.41
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 5
- group Id
- OG005
- value
- 2
- group Id
- OG006
- value
- 7
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 19
- units
- Participants
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Flat dose level; 0.15mg (Dose Level 1)
- id
- OG000
- title
- Part A Dose Level 1 NM21-1480-Q2W 0.15mg
- description
- Flat dose level; 1.5mg (Dose Level 2)
- id
- OG001
- title
- Part A Dose Level 2 NM21-1480-Q2W 1.5mg
- description
- Flat dose level; 8mg (Dose Level 3)
- id
- OG002
- title
- Part A Dose Level 3 NM21-1480-Q2W 8mg
- description
- Flat dose level; 24mg (Dose Level 4)
- id
- OG003
- title
- Part A Dose Level 4 NM21-1480-Q2W 24mg
- description
- Flat dose level; 80mg (Dose Level 5)
- id
- OG004
- title
- Part A Dose Level 5 NM21-1480-Q2W 80mg
- description
- Flat dose level; 240mg (Dose Level 6)
- id
- OG005
- title
- Part A Dose Level 6 NM21-1480-Q2W 240mg
- description
- Flat dose level; mg800 (Dose Level 7)
- id
- OG006
- title
- Part A Dose Level 7 NM21-1480-Q2W 800mg
- description
- This part of the study consisted of a 1400mg flat dose across one cohort.
- id
- OG007
- title
- Part A2 NM21-1480-Q2W
- description
- This part of the study consisted of a 800mg flat dose across three cohorts.
- id
- OG008
- title
- Part B NM21-1480-Q2W
- param Type
- MEDIAN
- population Description
- Progression-Free Survival (PFS) is defined as the time from the start of study treatment until the earliest documented date of disease progression or death. \[1\] Q1, Median and Q3 are Kaplan-Meier estimates and the 2-sided 95% confidence interval for median is calculated using the Brookmeyer-Crowley method.
- reporting Status
- POSTED
- time Frame
- From baseline to up to 12 weeks post last dose, up to 48 weeks.
- title
- To Determine the Anti-tumor Activity (Progression-free Survival) of NM21-1480 According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice