TriangleNCT02257567 · OUTCOME
Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- L
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
What was measured
PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
Analysis population: PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and obinutuzumab.
Groups in this outcome
Arm E (Phase II Expansion): Pola+BG in FL
Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
Arm F (Phase II Expansion): Pola+BG in DLBCL
Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 14 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 12 |
Reported measurements
acMMAE
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
Total Ab
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
Unconjugated MMAE
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
Bendamustine
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 14 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 12 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 51.2 | 33.6 | Not reported | Not reported | Not reported |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 31.5 | 68.1 | Not reported | Not reported | Not reported |
Obinutuzumab
| Group | Source count |
|---|---|
| Arm E (Phase II Expansion): Pola+BG in FL | 0 |
| Arm F (Phase II Expansion): Pola+BG in DLBCL | 0 |
Complete source fields
- classes
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- acMMAE
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Total Ab
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Unconjugated MMAE
- categories
- measurements
- group Id
- OG000
- spread
- 33.6
- value
- 51.2
- group Id
- OG001
- spread
- 68.1
- value
- 31.5
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- units
- Participants
- title
- Bendamustine
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Obinutuzumab
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- PK of three pola-related analytes: acMMAE, total antibody, and unconjugated MMAE were measured.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with FL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 28 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
- id
- OG000
- title
- Arm E (Phase II Expansion): Pola+BG in FL
- description
- Participants with DLBCL received pola, 1.8 mg/kg, as IV infusion on Day 2 of Cycle 1 (each cycle is 21 days), and thereafter on Day 1 of Cycles 2 to 6. Participants also received bendamustine 90 mg/m\^2, as IV infusion on Days 2 and 3 of Cycle 1, and thereafter on Days 1 and 2 of Cycles 2 to 6 and obinutuzumab 1000 mg, as IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 in combination with pola.
- id
- OG001
- title
- Arm F (Phase II Expansion): Pola+BG in DLBCL
- param Type
- GEOMETRIC_MEAN
- population Description
- PK evaluable population included all the ITT participants in Arms E and F who received at least one study treatment and who provided suitable PK samples. 'Overall Number Analyzed' are the number of participants with data available for analysis. 'Number Analyzed' is the number of participants with data available for analysis at a specified timepoints. Due to the sparse sample collection schema Vss was not evaluated for pola and obinutuzumab.
- reporting Status
- POSTED
- time Frame
- Cycle 1 Day 2 (cycle length is 21 days for DLBCL cohorts and 28 days for FL cohorts)
- title
- Phase II: Vss of Polatuzumab Vedotin, Bendamustine and Obinutuzumab in Arms E and F
- type
- SECONDARY
- unit Of Measure
- L
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Preserved source evidence · Not medical advice