TriangleNCT02327078 · OUTCOME
Phase 1, Part 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
- Day 42
What was measured
A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT \> 3 × upper limit of normal (ULN) and concurrent total bilirubin \> 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
Analysis population: The Phase 1, Part 1 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.
Groups in this outcome
Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
| Group | Source count |
|---|---|
| Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg | 3 |
| Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg | 6 |
| Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg | 14 |
| Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg | 13 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg | 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
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 13
- units
- Participants
- description
- A DLT was defined as occurrence of any treatment-emergent adverse event (TEAE) in Phase 1 Parts 1 and 2. DLT included all TEAE of specified grades such as 1) Hematologic toxicities - any Grade 4 thrombocytopenia or neutropenia, anemia, febrile neutropenia, ≥ Grade 3 hemolysis, thrombocytopenia and 2) Nonhematologic toxicities - Grade 4 AE, nausea, vomiting, or diarrhea, electrolyte abnormality, ≥ Grade 3 aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin elevation, Grade 2 AST/ALT with symptomatic liver inflammation, AST or ALT \> 3 × upper limit of normal (ULN) and concurrent total bilirubin \> 2 × ULN without initial findings of cholestasis, and any other ≥ Grade 3 toxicity. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and up to 100 days after last dose of study drug.
- groups
- description
- Participants received epacadostat 25 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG000
- title
- Phase 1, Part 1: Epacadostat 25 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 50 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG001
- title
- Phase 1, Part 1: Epacadostat 50 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 100 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG002
- title
- Phase 1, Part 1: Epacadostat 100 mg + Nivolumab 3 mg
- description
- Participants received epacadostat 300 mg, orally, BID in combination of nivolumab 3 mg/kg, IV, Q3W, on Days 1, 15, 29, and 43 of each 8-week cycle.
- id
- OG003
- title
- Phase 1, Part 1: Epacadostat 300 mg + Nivolumab 3 mg
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The Phase 1, Part 1 Safety Population includes all participants enrolled in the study who received at least 1 dose of study drug.
- reporting Status
- POSTED
- time Frame
- Day 42
- title
- Phase 1, Part 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