TriangleNCT03439280 · OUTCOME
Cmax: Maximum Observed Serum 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
- nanograms per milliliter (ng/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)
Analysis population: Pharmacokinetic (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. 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 | 22 |
| 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 | 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 | 22 |
| 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 | 47.0 | 1908.7 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 1660 | 460.1 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 5810 | 599.9 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 21300 | 196.6 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 46000 | 58.0 | Not reported | Not reported | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 5690 | 223.5 | 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 | 16 |
| 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 | 228 | 4373.4 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 12900 | 142.3 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 42700 | 86.3 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 143000 | 66.2 | Not reported | Not reported | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 174000 | 76.3 | Not reported | Not reported | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 25800 | 69.8 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 1908.7
- value
- 47.0
- group Id
- OG001
- spread
- 460.1
- value
- 1660
- group Id
- OG002
- spread
- 599.9
- value
- 5810
- group Id
- OG003
- spread
- 196.6
- value
- 21300
- group Id
- OG004
- spread
- 58.0
- value
- 46000
- group Id
- OG005
- spread
- 223.5
- value
- 5690
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 12
- group Id
- OG003
- value
- 22
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 6
- units
- Participants
- title
- Cycle 1 Week 1
- categories
- measurements
- group Id
- OG000
- spread
- 4373.4
- value
- 228
- group Id
- OG001
- spread
- 142.3
- value
- 12900
- group Id
- OG002
- spread
- 86.3
- value
- 42700
- group Id
- OG003
- spread
- 66.2
- value
- 143000
- group Id
- OG004
- spread
- 76.3
- value
- 174000
- group Id
- OG005
- spread
- 69.8
- value
- 25800
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 16
- 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
- 22
- 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
- Pharmacokinetic (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. Number analyzed is the number of participants with data available for analysis at the given timepoint.
- reporting Status
- POSTED
- time Frame
- Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 168 hours) post-dose (cycle length=28 days)
- title
- Cmax: Maximum Observed Serum Concentration for TAK-079
- type
- SECONDARY
- unit Of Measure
- nanograms per milliliter (ng/mL)
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Preserved source evidence · Not medical advice