TriangleNCT02431559 · OUTCOME
Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
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
- Up to 3.05 years
What was measured
The primary endpoint in Phase 1 and a secondary endpoint in Phase 2 is the safety/tolerability of study treatment. Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. Treatment-emergent AEs are those that occurred or worsened after administration of the first dose of study treatment.
Analysis population: The population comprises all subjects who received at least one dose of study treatment.
Groups in this outcome
Phase 1, Dose Level 0a
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
Phase 1, Dose Level 0b
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
Phase 1, Dose Level +1
Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
Phase 2
Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
| Group | Source count |
|---|---|
| Phase 1, Dose Level 0a | 3 |
| Phase 1, Dose Level 0b | 4 |
| Phase 1, Dose Level +1 | 6 |
| Phase 2 | 40 |
Reported measurements
Any TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 40 | Not reported | Not reported | Not reported | Not reported |
TEAE related to any study treatment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 38 | Not reported | Not reported | Not reported | Not reported |
TEAE related to durvalumab
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 32 | Not reported | Not reported | Not reported | Not reported |
TEAE related to PLD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 5 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 37 | Not reported | Not reported | Not reported | Not reported |
TEAE related to motolimod
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 3 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 4 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 6 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Serious TEAE
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1, Dose Level 0a | 0 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level 0b | 2 | Not reported | Not reported | Not reported | Not reported |
| Phase 1, Dose Level +1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Phase 2 | 23 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 40
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 38
- title
- TEAE related to any study treatment
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 32
- title
- TEAE related to durvalumab
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 37
- title
- TEAE related to PLD
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- title
- TEAE related to motolimod
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 23
- title
- Serious TEAE
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 40
- units
- Participants
- description
- The primary endpoint in Phase 1 and a secondary endpoint in Phase 2 is the safety/tolerability of study treatment. Toxicity is graded in accordance with the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03. Adverse events (AEs) are reported based on clinical laboratory tests, vital signs, physical examinations, and any other medically indicated assessments, including subject interviews, from the time informed consent is signed through 90 days after the last dose of study treatment. Treatment-emergent AEs are those that occurred or worsened after administration of the first dose of study treatment.
- groups
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (3 mg/kg Q2W \[equivalent to 450 mg Q4W\] IV on Days 3 and 17 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Days 3 and 17 of Cycles 4-12.
- id
- OG000
- title
- Phase 1, Dose Level 0a
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.0 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
- id
- OG001
- title
- Phase 1, Dose Level 0b
- description
- Subjects received PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment. Prior to removal of motolimod from the study, subjects received motolimod (2.5 mg/m\^2 SC) on Days 3, 10, and 17 of Cycles 1-3 and Day 3 of Cycles 4-12.
- id
- OG002
- title
- Phase 1, Dose Level +1
- description
- Subjects received the MTD determined in Phase 1, comprising PLD (40 mg/m\^2 IV on Day 1 of every cycle) + durvalumab (1500 mg Q4W IV on Day 3 of every cycle) for up to 12 continuous 28-day cycles (Core Study), with extended durvalumab monotherapy permitted for subjects tolerating and benefiting from treatment.
- id
- OG003
- title
- Phase 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The population comprises all subjects who received at least one dose of study treatment.
- reporting Status
- POSTED
- time Frame
- Up to 3.05 years
- title
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice