TriangleNCT01457417 · OUTCOME
Summary of Total Adverse Events (AE)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Events
- Interval / dispersion
- Not reported
- Time frame
- Baseline to study completion (approximately 3 months)
What was measured
Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.
Analysis population: Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.
Groups in this outcome
75 Milligram (mg) DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
150 mg DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part A (QW)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
600 mg DKN-01 Part A (Q2W)
DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
300 mg DKN-01 Part B (Q2W)
Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
Total
Total across all treatment groups
| Group | Source count |
|---|---|
| 75 Milligram (mg) DKN-01 Part A (QW) | 3 |
| 150 mg DKN-01 Part A (QW) | 3 |
| 300 mg DKN-01 Part A (QW) | 4 |
| 600 mg DKN-01 Part A (Q2W) | 3 |
| 300 mg DKN-01 Part B (Q2W) | 19 |
| Total | 32 |
Reported measurements
Total AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 75 Milligram (mg) DKN-01 Part A (QW) | 39 | Not reported | Not reported | Not reported | Not reported |
| 150 mg DKN-01 Part A (QW) | 58 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part A (QW) | 35 | Not reported | Not reported | Not reported | Not reported |
| 600 mg DKN-01 Part A (Q2W) | 11 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part B (Q2W) | 87 | Not reported | Not reported | Not reported | Not reported |
| Total | 230 | Not reported | Not reported | Not reported | Not reported |
Total TEAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 75 Milligram (mg) DKN-01 Part A (QW) | 39 | Not reported | Not reported | Not reported | Not reported |
| 150 mg DKN-01 Part A (QW) | 58 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part A (QW) | 35 | Not reported | Not reported | Not reported | Not reported |
| 600 mg DKN-01 Part A (Q2W) | 9 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part B (Q2W) | 87 | Not reported | Not reported | Not reported | Not reported |
| Total | 228 | Not reported | Not reported | Not reported | Not reported |
Total SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 75 Milligram (mg) DKN-01 Part A (QW) | 2 | Not reported | Not reported | Not reported | Not reported |
| 150 mg DKN-01 Part A (QW) | 7 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part A (QW) | 3 | Not reported | Not reported | Not reported | Not reported |
| 600 mg DKN-01 Part A (Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part B (Q2W) | 11 | Not reported | Not reported | Not reported | Not reported |
| Total | 23 | Not reported | Not reported | Not reported | Not reported |
Total DLTs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 75 Milligram (mg) DKN-01 Part A (QW) | 0 | Not reported | Not reported | Not reported | Not reported |
| 150 mg DKN-01 Part A (QW) | 0 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part A (QW) | 0 | Not reported | Not reported | Not reported | Not reported |
| 600 mg DKN-01 Part A (Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| 300 mg DKN-01 Part B (Q2W) | 0 | Not reported | Not reported | Not reported | Not reported |
| Total | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 11
- group Id
- OG004
- value
- 87
- group Id
- OG005
- value
- 230
- title
- Total AEs
- categories
- measurements
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 35
- group Id
- OG003
- value
- 9
- group Id
- OG004
- value
- 87
- group Id
- OG005
- value
- 228
- title
- Total TEAEs
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 11
- group Id
- OG005
- value
- 23
- title
- Total SAEs
- 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
- title
- Total DLTs
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 19
- group Id
- OG005
- value
- 32
- units
- Participants
- description
- Total Adverse Events (AE), total treatment emergent adverse events (TEAE), total Serious Adverse Events (SAE), and total dose-limiting toxicity (DLT) for both Parts A and B.
- groups
- description
- DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
- id
- OG000
- title
- 75 Milligram (mg) DKN-01 Part A (QW)
- description
- DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
- id
- OG001
- title
- 150 mg DKN-01 Part A (QW)
- description
- DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
- id
- OG002
- title
- 300 mg DKN-01 Part A (QW)
- description
- DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
- id
- OG003
- title
- 600 mg DKN-01 Part A (Q2W)
- description
- Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
- id
- OG004
- title
- 300 mg DKN-01 Part B (Q2W)
- description
- Total across all treatment groups
- id
- OG005
- title
- Total
- param Type
- NUMBER
- population Description
- Safety analyses were based on the full analysis set (FAS), which was defined as all patients who received at least one dose of study treatment during Part A or Part B of the study.
- reporting Status
- POSTED
- time Frame
- Baseline to study completion (approximately 3 months)
- title
- Summary of Total Adverse Events (AE)
- type
- PRIMARY
- unit Of Measure
- Events
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Preserved source evidence · Not medical advice