TriangleNCT03848845 · OUTCOME
Part 2 - Ctrough for Total mAb
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ug/mL
- Interval / dispersion
- Full Range
- Time frame
- Cycle 1 and Cycle 4
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
Analysis population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Groups in this outcome
Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 20 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 20 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 7.735 | Not reported | 1.28 | 12.70 | Not reported |
Cycle 4
| Group | Source count |
|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 7 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion | 11.60 | Not reported | 9.15 | 31.0 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1.28
- upper Limit
- 12.70
- value
- 7.735
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 9.15
- upper Limit
- 31.0
- value
- 11.60
- denoms
- counts
- group Id
- OG000
- value
- 7
- units
- Participants
- title
- Cycle 4
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. PK parameter was determined using standard non-compartmental methods.
- dispersion Type
- Full Range
- groups
- description
- Participants were administered belantamab mafodotin with recommended phase 2 dose (RP2D) of 2.5 mg/kg in combination with 200 mg of pembrolizumab via IV infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal, or for a maximum of 35 cycles.
- id
- OG000
- title
- Main Study Phase- Part 2: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Expansion
- param Type
- MEDIAN
- population Description
- Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Cycle 1 and Cycle 4
- title
- Part 2 - Ctrough for Total mAb
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice