TriangleNCT02268253 · OUTCOME
Number of Participants With Dose-limiting Toxicities (DLTs)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants
- Interval / dispersion
- Not reported
- Time frame
- 21 days of Cycle 1 (21 days/cycle)
What was measured
During Stage 1, DLT was defined as any of the following occurring during the first cycle of therapy: any treatment-emergent Grade 4 transaminase or creatine phosphokinase (CPK) elevation (confirmed within 24 hours of initial identification), regardless of duration or relationship to SL-401; any Grade ≥3 non-hematologic toxicity (unrelated to underlying MPN), with the exception of Grade 3 laboratory toxicities that resolve to Grade ≤1 or baseline ≤28 days after the last infusion of SL-401, or the following Grade 3 toxicities if they resolve to Grade ≤1 or baseline ≤21 days after the last infusion of SL-401, arthralgia, myalgia, fever responding to treatment, nausea and/or vomiting (excluding cases that require tube feeding, total parenteral nutrition, or hospitalization) or diarrhea associated with suboptimal prophylaxis or treatment; Grade 4 neutropenia or Grade 4 thrombocytopenia with a duration (at Grade 4) of ≥28 days.
Analysis population: Safety Population: All participants who received at least 1 dose of study drug during Stage 1 only. 'Dose Level 3 - Tagraxofusp - 12 μg/kg/Day - Advanced Systemic Mastocytosis' arm enrolled during Stage 2. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure in Stage 1 only.
Groups in this outcome
Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis
Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
| Group | Source count |
|---|---|
| Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia | 1 |
| Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia | 2 |
| Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia | 2 |
| Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis | 2 |
| Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis | 1 |
| Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis | 1 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis | 0 | Not reported | Not reported | Not reported | Not reported |
| Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 1
- units
- Participants
- description
- During Stage 1, DLT was defined as any of the following occurring during the first cycle of therapy: any treatment-emergent Grade 4 transaminase or creatine phosphokinase (CPK) elevation (confirmed within 24 hours of initial identification), regardless of duration or relationship to SL-401; any Grade ≥3 non-hematologic toxicity (unrelated to underlying MPN), with the exception of Grade 3 laboratory toxicities that resolve to Grade ≤1 or baseline ≤28 days after the last infusion of SL-401, or the following Grade 3 toxicities if they resolve to Grade ≤1 or baseline ≤21 days after the last infusion of SL-401, arthralgia, myalgia, fever responding to treatment, nausea and/or vomiting (excluding cases that require tube feeding, total parenteral nutrition, or hospitalization) or diarrhea associated with suboptimal prophylaxis or treatment; Grade 4 neutropenia or Grade 4 thrombocytopenia with a duration (at Grade 4) of ≥28 days.
- groups
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG000
- title
- Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Chronic Myelomonocytic Leukemia
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG001
- title
- Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Chronic Myelomonocytic Leukemia
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG002
- title
- Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Chronic Myelomonocytic Leukemia
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG003
- title
- Dose Level 1 - Tagraxofusp - 7 µg/kg/Day - Myelofibrosis
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG004
- title
- Dose Level 2 - Tagraxofusp - 9 µg/kg/Day - Myelofibrosis
- description
- Tagraxofusp was administered as a 15-minute IV infusion once daily for the first 3 consecutive days of each dosing cycle.
- id
- OG005
- title
- Dose Level 3 - Tagraxofusp - 12 µg/kg/Day - Myelofibrosis
- param Type
- NUMBER
- population Description
- Safety Population: All participants who received at least 1 dose of study drug during Stage 1 only. 'Dose Level 3 - Tagraxofusp - 12 μg/kg/Day - Advanced Systemic Mastocytosis' arm enrolled during Stage 2. Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure in Stage 1 only.
- reporting Status
- POSTED
- time Frame
- 21 days of Cycle 1 (21 days/cycle)
- title
- Number of Participants With Dose-limiting Toxicities (DLTs)
- type
- PRIMARY
- unit Of Measure
- participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice