TriangleNCT01451632 · OUTCOME
Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants reporting DLTs
- Interval / dispersion
- Not reported
- Time frame
- From date of first dose to 30 days after termination, the longest 48.1 weeks
What was measured
To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
Analysis population: Patients participating in dose escalation
Groups in this outcome
Part 1: Cohort 1
MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Part 1: Cohort 2a
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Part 1: Cohort 2b
MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 1: Cohort 3a
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
Part 1: Cohort 3b
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 1: Cohort 4
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
Part 2: Cohort 1
MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
Part 2: Cohort 2
MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
| Group | Source count |
|---|---|
| Part 1: Cohort 1 | 8 |
| Part 1: Cohort 2a | 4 |
| Part 1: Cohort 2b | 3 |
| Part 1: Cohort 3a | 3 |
| Part 1: Cohort 3b | 4 |
| Part 1: Cohort 4 | 4 |
| Part 2: Cohort 1 | 6 |
| Part 2: Cohort 2 | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cohort 2a | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cohort 2b | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cohort 3a | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cohort 3b | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Cohort 4 | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Cohort 2 | 2 | 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
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- group Id
- OG006
- value
- 1
- group Id
- OG007
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 4
- group Id
- OG005
- value
- 4
- group Id
- OG006
- value
- 6
- group Id
- OG007
- value
- 4
- units
- Participants
- description
- To establish the safety of escalating doses of MM-121 in combination with cetuximab or in combination with cetuximab and irinotecan in order to determine the recommended phase 2 dose.. Dose-escalation conducted using standard 3+3 model to determine maximum tolerated dose. Reports of Dose-Limiting Toxicities (DLTs) were assessed to determine the MTD.
- groups
- description
- MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
- id
- OG000
- title
- Part 1: Cohort 1
- description
- MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
- id
- OG001
- title
- Part 1: Cohort 2a
- description
- MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
- id
- OG002
- title
- Part 1: Cohort 2b
- description
- MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
- id
- OG003
- title
- Part 1: Cohort 3a
- description
- MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
- id
- OG004
- title
- Part 1: Cohort 3b
- description
- MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
- id
- OG005
- title
- Part 1: Cohort 4
- description
- MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
- id
- OG006
- title
- Part 2: Cohort 1
- description
- MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
- id
- OG007
- title
- Part 2: Cohort 2
- param Type
- NUMBER
- population Description
- Patients participating in dose escalation
- reporting Status
- POSTED
- time Frame
- From date of first dose to 30 days after termination, the longest 48.1 weeks
- title
- Dose Escalation: To Evaluate the Safety and Tolerability of Escalating Doses of the MM-121 Plus Cetuximab and the MM-121 Plus Cetuximab Plus Irinotecan Combination
- type
- PRIMARY
- unit Of Measure
- participants reporting DLTs
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice