TriangleNCT03439280 · OUTCOME
Tmax: Time to Reach the Maximum Observed Serum Concentration (Cmax) for TAK-079
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- hours (h)
- Interval / dispersion
- Full Range
- Time frame
- Cycles 1 and 2: Day 1 pre-dose and at multiple time points (up to 190.95 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. 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 progressive disease (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 | 60.18 | Not reported | 22.88 | 168.00 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 70.60 | Not reported | 49.35 | 167.88 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 71.11 | Not reported | 44.00 | 168.50 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 72.55 | Not reported | 24.00 | 190.95 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 73.22 | Not reported | 70.23 | 169.30 | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 70.58 | Not reported | 46.23 | 173.50 | 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 | 58.77 | Not reported | 0.10 | 70.40 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 135 mg | 71.15 | Not reported | 22.78 | 168.57 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 300 mg | 70.00 | Not reported | 0 | 167.00 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 600 mg | 59.12 | Not reported | 0.25 | 172.53 | Not reported |
| Phase 1 Dose Escalation Cohort: Mezagitamab 1200 mg | 71.92 | Not reported | 48.88 | 165.12 | Not reported |
| Phase 1 Combination Cohort: Mezagitamab 300 mg + PomDex | 49.33 | Not reported | 5.67 | 70.85 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.88
- upper Limit
- 168.00
- value
- 60.18
- group Id
- OG001
- lower Limit
- 49.35
- upper Limit
- 167.88
- value
- 70.60
- group Id
- OG002
- lower Limit
- 44.00
- upper Limit
- 168.50
- value
- 71.11
- group Id
- OG003
- lower Limit
- 24.00
- upper Limit
- 190.95
- value
- 72.55
- group Id
- OG004
- lower Limit
- 70.23
- upper Limit
- 169.30
- value
- 73.22
- group Id
- OG005
- lower Limit
- 46.23
- upper Limit
- 173.50
- value
- 70.58
- 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
- lower Limit
- 0.10
- upper Limit
- 70.40
- value
- 58.77
- group Id
- OG001
- lower Limit
- 22.78
- upper Limit
- 168.57
- value
- 71.15
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 167.00
- value
- 70.00
- group Id
- OG003
- lower Limit
- 0.25
- upper Limit
- 172.53
- value
- 59.12
- group Id
- OG004
- lower Limit
- 48.88
- upper Limit
- 165.12
- value
- 71.92
- group Id
- OG005
- lower Limit
- 5.67
- upper Limit
- 70.85
- value
- 49.33
- 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
- Full Range
- 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 progressive disease (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
- MEDIAN
- 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. 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 190.95 hours) post-dose (cycle length=28 days)
- title
- Tmax: Time to Reach the Maximum Observed Serum Concentration (Cmax) for TAK-079
- type
- SECONDARY
- unit Of Measure
- hours (h)
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Preserved source evidence · Not medical advice