TriangleNCT03439280 · OUTCOME
AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- hours*nanogram/milliliter (h*ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)
Analysis population: PK analysis set included those participants from the safety analysis set who had sufficient dosing data and mezagitamab concentration-time data to permit the calculation of PK parameters. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.
Groups in this outcome
Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 4 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 3 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 12 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 21 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 3 |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 6 |
Reported measurements
Cycle 1 Week 1
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 2 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 3 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 12 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 21 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 3 |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 32800 | 20.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 160000 | 471.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 547000 | 546.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 2710000 | 83.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 5780000 | 67.7 | Not reported | Not reported | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 603000 | 272.9 | Not reported | Not reported | Not reported |
Cycle 2 Week 1
| Group | Source count |
|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 4 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 3 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 11 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 15 |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 3 |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 6 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg | 10400 | 285970.0 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 1920000 | 159.8 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 4780000 | 114.5 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 19300000 | 79.6 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 27000000 | 92.1 | Not reported | Not reported | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 2690000 | 33.9 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 20.9
- value
- 32800
- group Id
- OG001
- spread
- 471.1
- value
- 160000
- group Id
- OG002
- spread
- 546.9
- value
- 547000
- group Id
- OG003
- spread
- 83.8
- value
- 2710000
- group Id
- OG004
- spread
- 67.7
- value
- 5780000
- group Id
- OG005
- spread
- 272.9
- value
- 603000
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Cycle 1 Week 1
- categories
- measurements
- group Id
- OG000
- spread
- 285970.0
- value
- 10400
- group Id
- OG001
- spread
- 159.8
- value
- 1920000
- group Id
- OG002
- spread
- 114.5
- value
- 4780000
- group Id
- OG003
- spread
- 79.6
- value
- 19300000
- group Id
- OG004
- spread
- 92.1
- value
- 27000000
- group Id
- OG005
- spread
- 33.9
- value
- 2690000
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 15
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Cycle 2 Week 1
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 21
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Mezagitamab 45 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG000
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 45 mg
- description
- Mezagitamab 135 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG001
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG002
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg
- description
- Mezagitamab 600 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG003
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg
- description
- Mezagitamab 1200 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter in a 28-day treatment cycle until PD, unacceptable toxicities or withdrawal due to other reasons.
- id
- OG004
- title
- Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg
- description
- Mezagitamab 300 mg, SC, once weekly for 8 weeks, then once every 2 weeks for 16 weeks, and then once every 4 weeks thereafter along with pomalidomide, at product-labelled dose, orally, once daily on Days 1 to 21 and dexamethasone, at product-labelled dose, orally, once on Days 1, 8, 15, and 22 in a 28-day treatment cycle until PD.
- id
- OG005
- title
- Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex
- param Type
- GEOMETRIC_MEAN
- population Description
- PK analysis set included those participants from the safety analysis set who had sufficient dosing data and mezagitamab concentration-time data to permit the calculation of PK parameters. Overall number analyzed is the number of participants available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)
- title
- AUClast: Area Under the Serum Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-079
- type
- SECONDARY
- unit Of Measure
- hours*nanogram/milliliter (h*ng/mL)
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Preserved source evidence · Not medical advice