TriangleNCT03215030 · OUTCOME
Parts 2 and 3: Overall Survival (OS)
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
- Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
What was measured
The OS was defined as the time from the date of first dose to the date of death due to any cause.
Analysis population: The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
Groups in this outcome
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 120 mg
Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
Part 3 (Dose Extension): Modakafusp Alfa 240 mg
Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
| Group | Source count |
|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | 3 |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | 1 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | 3 |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 2 |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | 18 |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | 17 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa | NA | Not reported | 1.5 | 19.9 | Median was not reached. |
| Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone | NA | Not reported | 1.7 | 15.2 | Median was not reached. |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa | NA | Not reported | 0.5 | 22.3 | Median was not reached. |
| Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone | 3.4 | Not reported | 1.0 | 3.7 | Not reported |
| Part 3 (Dose Extension): Modakafusp Alfa 120 mg | NA | Not reported | 1.08 | 17.25 | Median was not reached. |
| Part 3 (Dose Extension): Modakafusp Alfa 240 mg | NA | Not reported | 0.39 | 19.81 | Median was not reached. |
Complete source fields
- classes
- categories
- measurements
- comment
- Median was not reached.
- group Id
- OG000
- lower Limit
- 1.5
- upper Limit
- 19.9
- value
- NA
- comment
- Median was not reached.
- group Id
- OG001
- lower Limit
- 1.7
- upper Limit
- 15.2
- value
- NA
- comment
- Median was not reached.
- group Id
- OG002
- lower Limit
- 0.5
- upper Limit
- 22.3
- value
- NA
- group Id
- OG003
- lower Limit
- 1.0
- upper Limit
- 3.7
- value
- 3.4
- comment
- Median was not reached.
- group Id
- OG004
- lower Limit
- 1.08
- upper Limit
- 17.25
- value
- NA
- comment
- Median was not reached.
- group Id
- OG005
- lower Limit
- 0.39
- upper Limit
- 19.81
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 18
- group Id
- OG005
- value
- 17
- units
- Participants
- description
- The OS was defined as the time from the date of first dose to the date of death due to any cause.
- dispersion Type
- Full Range
- groups
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG000
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa
- description
- Participants received modakafusp alfa 0.400 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
- id
- OG001
- title
- Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG002
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa
- description
- Participants received modakafusp alfa 1.500 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
- id
- OG003
- title
- Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa + Dexamethasone
- description
- Participants received modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG004
- title
- Part 3 (Dose Extension): Modakafusp Alfa 120 mg
- description
- Participants received modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.
- id
- OG005
- title
- Part 3 (Dose Extension): Modakafusp Alfa 240 mg
- param Type
- MEDIAN
- population Description
- The SAS included all enrolled participants who received at least 1 dose, even if incomplete, of TAK-573. The FAS included all participants who received at least 1 dose, even an incomplete dose, of modakafusp alfa, in the Part 3 extension cohorts. Overall number of participants analyzed is the number of participants with data available for analyses.
- reporting Status
- POSTED
- time Frame
- Up to 34.7 months in Part 2; Up to 20.5 months in Part 3
- title
- Parts 2 and 3: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice