TriangleNCT02460224 · OUTCOME
Phase 1: 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
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
What was measured
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Analysis population: All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms. Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.
Groups in this outcome
Phase 1: LAG525 1 mg/kg Q2W
Single-agent LAG525 1 mg/kg Q2W
Phase 1: LAG525 3 mg/kg Q2W
Single-agent LAG525 3 mg/kg Q2W
Phase 1: LAG525 5 mg/kg Q2W
Single-agent LAG525 5 mg/kg Q2W
Phase 1: LAG525 10 mg/kg Q2W
Single-agent LAG525 10 mg/kg Q2W
Phase 1: LAG525 15 mg/kg Q2W
Single-agent LAG525 15 mg/kg Q2W
Phase 1: LAG525 240 mg Q2W
Single-agent LAG525 240 mg Q2W
Phase 1: LAG525 400 mg Q2W
Single-agent LAG525 400 mg Q2W
Phase 1: LAG525 3 mg/kg Q4W
Single-agent LAG525 3 mg/kg Q4W
Phase 1: LAG525 5 mg/kg Q4W
Single-agent LAG525 5 mg/kg Q4W
Phase 1: LAG525 10 mg/kg Q4W
Single-agent LAG525 10 mg/kg Q4W
Phase 1: LAG525 400 mg Q4W
Single-agent LAG525 400 mg Q4W
Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W
Combination LAG525 1 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W
Combination LAG525 80 mg + PDR001 80 mg (Q2W/Q2W)
Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 80 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W
Combination LAG525 240 mg + PDR001 240 mg (Q2W/Q2W)
Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 240 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 400 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W
Combination LAG525 600 mg + PDR001 300 mg (Q3W/Q3W)
Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W
Combination LAG525 80 mg + PDR001 240 mg (Q4W/Q4W)
Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 400 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 800 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W
Combination LAG525 1000 mg + PDR001 400 mg (Q4W/Q4W)
Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 80 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 240 mg + PDR001 400 mg (Q2W/Q4W)
Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W
Combination LAG525 300 mg + PDR001 400 mg (Q2W/Q4W)
| Group | Source count |
|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 16 |
| Phase 1: LAG525 3 mg/kg Q2W | 12 |
| Phase 1: LAG525 5 mg/kg Q2W | 6 |
| Phase 1: LAG525 10 mg/kg Q2W | 5 |
| Phase 1: LAG525 15 mg/kg Q2W | 6 |
| Phase 1: LAG525 240 mg Q2W | 28 |
| Phase 1: LAG525 400 mg Q2W | 27 |
| Phase 1: LAG525 3 mg/kg Q4W | 5 |
| Phase 1: LAG525 5 mg/kg Q4W | 6 |
| Phase 1: LAG525 10 mg/kg Q4W | 11 |
| Phase 1: LAG525 400 mg Q4W | 5 |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 5 |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 5 |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 17 |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 4 |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 9 |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 5 |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 6 |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 11 |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 5 |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1: LAG525 1 mg/kg Q2W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q2W | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 15 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 3 mg/kg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 5 mg/kg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 10 mg/kg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1 mg/kg Q2W + PDR001 1 mg/kg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 80 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 240 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 240 mg Q2W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q3W + PDR001 300 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q3W + PDR001 300 mg Q3W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 600 mg Q3W + PDR001 300 mg Q3W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q4W + PDR001 240 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 400 mg Q4W + PDR001 400 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 800 mg Q4W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 1000 mg Q4W + PDR001 400 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 80 mg Q2W + PDR001 400 mg Q4W | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 240 mg Q2W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1: LAG525 300 mg Q2W + PDR001 400 mg Q4W | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 0
- group Id
- OG007
- value
- 0
- group Id
- OG008
- value
- 0
- group Id
- OG009
- value
- 1
- group Id
- OG010
- value
- 0
- group Id
- OG011
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 6
- group Id
- OG005
- value
- 28
- group Id
- OG006
- value
- 27
- group Id
- OG007
- value
- 5
- group Id
- OG008
- value
- 6
- group Id
- OG009
- value
- 11
- group Id
- OG010
- value
- 5
- group Id
- OG011
- value
- 6
- units
- Participants
- description
- A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first cycle of treatment with single-agent LAG525 or within the first two cycles of treatment with the combination of LAG525 and PDR001. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
- groups
- description
- Single-agent LAG525 1 mg/kg Q2W
- id
- OG000
- title
- Phase 1: LAG525 1 mg/kg Q2W
- description
- Single-agent LAG525 3 mg/kg Q2W
- id
- OG001
- title
- Phase 1: LAG525 3 mg/kg Q2W
- description
- Single-agent LAG525 5 mg/kg Q2W
- id
- OG002
- title
- Phase 1: LAG525 5 mg/kg Q2W
- description
- Single-agent LAG525 10 mg/kg Q2W
- id
- OG003
- title
- Phase 1: LAG525 10 mg/kg Q2W
- description
- Single-agent LAG525 15 mg/kg Q2W
- id
- OG004
- title
- Phase 1: LAG525 15 mg/kg Q2W
- description
- Single-agent LAG525 240 mg Q2W
- id
- OG005
- title
- Phase 1: LAG525 240 mg Q2W
- description
- Single-agent LAG525 400 mg Q2W
- id
- OG006
- title
- Phase 1: LAG525 400 mg Q2W
- description
- Single-agent LAG525 3 mg/kg Q4W
- id
- OG007
- title
- Phase 1: LAG525 3 mg/kg Q4W
- description
- Single-agent LAG525 5 mg/kg Q4W
- id
- OG008
- title
- Phase 1: LAG525 5 mg/kg Q4W
- description
- Single-agent LAG525 10 mg/kg Q4W
- id
- OG009
- title
- Phase 1: LAG525 10 mg/kg Q4W
- description
- Single-agent LAG525 400 mg Q4W
- id
- OG010
- title
- Phase 1: LAG525 400 mg Q4W
- description
- Combination LAG525 0.3 mg/kg + PDR001 1 mg/kg (Q2W/Q2W)
- id
- OG011
- title
- Phase 1: LAG525 0.3 mg/kg Q2W + PDR001 1 mg/kg Q2W
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All patients in phase 1 who received at least one full or partial dose of LAG525 or PDR001, and who either completed a minimum exposure requirement or who had a DLT during the first 15 days of treatment (1 cycle) for single-agent LAG525 arms or the first 30 days (2 cycles) for the LAG525 + PDR001 arms. Japanese patients were analyzed together with the rest of the world (ROW) patients as per protocol.
- reporting Status
- POSTED
- time Frame
- 15 days for single-agent LAG525 arms and 30 days for the combination LAG525 + PDR001 arms
- title
- Phase 1: 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